search
Back to results

Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction (COOPERATION)

Primary Purpose

ST-segment Elevation Myocardial Infarction (STEMI), Percutaneous Coronary Intervention, Cardioprotection

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine (DEX)
Placebo (Saline)
Sponsored by
Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ST-segment Elevation Myocardial Infarction (STEMI) focused on measuring ST-segment Elevation Myocardial Infarction (STEMI), Percutaneous coronary intervention, Dexmedetomidine, Cardioprotection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: the enrolled subjects must meet all of the following criteria:

  • Aged 18-75 years old (inclusive);
  • Diagnosed with anterior STEMI within 6h of symptom onset: (1) ischemic chest discomfort; (2) electrocardiogram (ECG) with ST elevation ≥0.2 mV in 2 or more contiguous precordial leads (one of which should be V2, V3, or V4);
  • Sign the informed consent form.

Exclusion Criteria: subjects who meet any one of the following criteria are excluded from the study:

  • Ventricular fibrillation, cardiogenic shock, Killip III-IV grade;
  • Sinus bradycardia (heart rate sustained <60 beats/min), PR interval> 240ms or II-III degree atrioventricular block;
  • Continuous systolic blood pressure <120mmHg;
  • Severe breathing difficulties, aterial blood oxygen saturation <92%;
  • Thrombolytic therapy has been performed before the first medical contact in the hospital;
  • Consciousness disorder or past cerebrovascular disease;
  • Previous history of myocardial infarction or PCI/CABG treatment;
  • Known severe liver and kidney dysfunction;
  • Known allergy to dexmedetomidine;
  • CMR contraindications: such as claustrophobia, pacemaker or ICD implantation;
  • Pregnant or lactating women;
  • Malignant tumor or expected survival time <1 year;
  • Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, poor compliance, inability of the patient to comply with study procedures and/or follow up);
  • Participate in other randomized controlled studies at the same time.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical UniversityRecruiting
  • The First Affiliated Hospital of Lanzhou UniversityRecruiting
  • The Second Affiliated Hospital of Harbin Medical UniversityRecruiting
  • Mudanjiang Cardiovascular HospitalRecruiting
  • Henan Provincial People's HospitalRecruiting
  • Wuhan Asia Heart HospitalRecruiting
  • Shaanxi Provincial People's HospitalRecruiting
  • Shanxi Cardiovascular HospitalRecruiting
  • Tianjin First Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine (DEX) group

Placebo (Saline) group

Arm Description

The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.

The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX group.

Outcomes

Primary Outcome Measures

Myocardial infarction size (MIS) evaluated by CMR 5±2 days post-STEMI.
MIS was measured by CMR delayed gadolinium enhancement（expressed as %LV myocardial mass).

Secondary Outcome Measures

Myocardial salvage index (MSI) evaluated by CMR 5±2 days post-STEMI.
MSI defined as: (area at risk - myocardial infarct size) / area at risk × 100.
Microvascular obstruction (MVO) evaluated by CMR 5±2 days post-STEMI.
MVO was evaluated qualitatively on delayed enhanced images; it was defined as hypodense regions within the hyperenhanced infracted area.
Left ventricular ejection fraction (LVEF) evaluated by CMR 5±2 days post-STEMI.
LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100.
The area under curve (AUC) for troponin I (cTnI) and creatine kinase-MB (CK-MB).
Myocardial ischemic injury markers refer to CK-MB and cTnI
The peak value for troponin I (cTnI) and creatine kinase-MB (CK-MB).
Myocardial ischemic injury markers refer to CK-MB and cTnI
LVEF evaluated by echocardiograhy at 30 days post-STEMI.
LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100.
Incidence of major adverse cardiovascular events (MACE): cardiac death, recurrent myocardial infarction, revascularization, rehospitalization due to heart failure.
Clinical follow-up is performed at 30 days, 3 months, 6 months, and 12 months. Follow-up at 30 days is in the outpatient clinic, other time frame follow-up is performed by phone call and clinical charts review.

Full Information

First Posted
May 12, 2021
Last Updated
November 22, 2021
Sponsor
Harbin Medical University
Collaborators
Yangtze River Pharmaceutical Group Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04912518
Brief Title
Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction
Acronym
COOPERATION
Official Title
Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction: a Double-Blind, Multicenter, Randomized, Placebo-Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harbin Medical University
Collaborators
Yangtze River Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a double-blind, multicenter, randomized, placebo-controlled clinical trial. It is planned to enroll patients admitted with anterior ST-segment elevation myocardial infarction (STEMI) within 6h of symptom onset and undergo primary percutaneous coronary intervention (pPCI). Patients who meet the inclusion criteria and without exclusion criteria were randomized 1:1 into the dexmedetomidine (DEX) group or the placebo (saline) group after signing the informed consent. In the DEX group, intravenous injection of DEX was started immediately after enrollment, covering the entire PCI operation, and the administration was stopped at the end of the pPCI. The administration of saline was the same as those in the DEX group. The primary endpoint was the myocardial infarct size (MIS) as assessed by cardiac magnetic resonance imaging (CMR) at 5±2 days post-STEMI. Based on a superiority design and assuming an 20.0% relative infarct size reduction (from 26.0% to 20.8% with a SD of 13.0%), 250 patients are required to be enrolled, accounting for 20% drop-out (α= 0.05 and power= 80%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction (STEMI), Percutaneous Coronary Intervention, Cardioprotection
Keywords
ST-segment Elevation Myocardial Infarction (STEMI), Percutaneous coronary intervention, Dexmedetomidine, Cardioprotection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine (DEX) group
Arm Type
Active Comparator
Arm Description
The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.
Arm Title
Placebo (Saline) group
Arm Type
Placebo Comparator
Arm Description
The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX group.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine (DEX)
Intervention Description
The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.
Intervention Type
Drug
Intervention Name(s)
Placebo (Saline)
Intervention Description
The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX.
Primary Outcome Measure Information:
Title
Myocardial infarction size (MIS) evaluated by CMR 5±2 days post-STEMI.
Description
MIS was measured by CMR delayed gadolinium enhancement（expressed as %LV myocardial mass).
Time Frame
5±2 days post-STEMI
Secondary Outcome Measure Information:
Title
Myocardial salvage index (MSI) evaluated by CMR 5±2 days post-STEMI.
Description
MSI defined as: (area at risk - myocardial infarct size) / area at risk × 100.
Time Frame
5±2 days post-STEMI
Title
Microvascular obstruction (MVO) evaluated by CMR 5±2 days post-STEMI.
Description
MVO was evaluated qualitatively on delayed enhanced images; it was defined as hypodense regions within the hyperenhanced infracted area.
Time Frame
5±2 days post-STEMI
Title
Left ventricular ejection fraction (LVEF) evaluated by CMR 5±2 days post-STEMI.
Description
LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100.
Time Frame
5±2 days post-STEMI
Title
The area under curve (AUC) for troponin I (cTnI) and creatine kinase-MB (CK-MB).
Description
Myocardial ischemic injury markers refer to CK-MB and cTnI
Time Frame
First medical contact in hospital (before drug administration, baseline), and return to ward immediately, 6 Hours, 12 Hours, 24 Hours, 48 Hours after PCI procedure
Title
The peak value for troponin I (cTnI) and creatine kinase-MB (CK-MB).
Description
Myocardial ischemic injury markers refer to CK-MB and cTnI
Time Frame
First medical contact in hospital (before drug administration, baseline), and return to ward immediately, 6 Hours, 12 Hours, 24 Hours, 48 Hours after PCI procedure
Title
LVEF evaluated by echocardiograhy at 30 days post-STEMI.
Description
LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100.
Time Frame
30 days post-STEMI
Title
Incidence of major adverse cardiovascular events (MACE): cardiac death, recurrent myocardial infarction, revascularization, rehospitalization due to heart failure.
Description
Clinical follow-up is performed at 30 days, 3 months, 6 months, and 12 months. Follow-up at 30 days is in the outpatient clinic, other time frame follow-up is performed by phone call and clinical charts review.
Time Frame
30 days and 12 months post-STEMI
Other Pre-specified Outcome Measures:
Title
The major prespecified safety endpoint: a composite of cardiac death during the first 24 hours after admission.
Description
A composite of cardiac death was defined death from cardiac causes
Time Frame
The first 24 hours after admission
Title
The major prespecified safety endpoint: II-III degree atrioventricular block during the first 24 hours after admission.
Description
Atrioventricular block is defined as the abnormal conduction of electrical activation between the atria and ventricles during the conduction of electrical activation of the heart, which can lead to arrhythmia and prevent the heart from contracting and pumping blood normally.
Time Frame
The first 24 hours after admission
Title
The major prespecified safety endpoint:severe sinus bradycardia during the first 24 hours after admission.
Description
Severe sinus bradycardia was defined as heart rate (HR) sustained <50 beats/min
Time Frame
The first 24 hours after admission
Title
The major prespecified safety endpoint:severe hypotension during the first 24 hours after admission.
Description
severe hypotension was defined as continuous systolic blood pressure <80mmHg
Time Frame
The first 24 hours after admission
Title
The major prespecified safety endpoint:malignant ventricular arrhythmia during the first 24 hours after admission.
Description
malignant ventricular arrhythmia including ventricular tachycardia and ventricular fibrillation.
Time Frame
The first 24 hours after admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: the enrolled subjects must meet all of the following criteria: Aged 18-75 years old (inclusive); Diagnosed with anterior STEMI within 6h of symptom onset: (1) ischemic chest discomfort; (2) electrocardiogram (ECG) with ST elevation ≥0.2 mV in 2 or more contiguous precordial leads (one of which should be V2, V3, or V4); Sign the informed consent form. Exclusion Criteria: subjects who meet any one of the following criteria are excluded from the study: Ventricular fibrillation, cardiogenic shock, Killip III-IV grade; Sinus bradycardia (heart rate sustained <60 beats/min), PR interval> 240ms or II-III degree atrioventricular block; Continuous systolic blood pressure <120mmHg; Severe breathing difficulties, aterial blood oxygen saturation <92%; Thrombolytic therapy has been performed before the first medical contact in the hospital; Consciousness disorder or past cerebrovascular disease; Previous history of myocardial infarction or PCI/CABG treatment; Known severe liver and kidney dysfunction; Known allergy to dexmedetomidine; CMR contraindications: such as claustrophobia, pacemaker or ICD implantation; Pregnant or lactating women; Malignant tumor or expected survival time <1 year; Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, poor compliance, inability of the patient to comply with study procedures and/or follow up); Participate in other randomized controlled studies at the same time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiannan Dai, M.D., Ph.D
Phone
+86 15124559838
Email
daijiannandr@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jinfeng Tan, M.D.
Phone
+86 13633643383
Email
418904005@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Yu, M.D., FACC
Organizational Affiliation
The Second Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xi Su
Organizational Affiliation
Wuhan Asia Heart Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaohui Zheng
Organizational Affiliation
Henan Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kai Liu
Organizational Affiliation
Mudanjiang cardiovascular hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian An
Organizational Affiliation
Shanxi Cardiovascular Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiling Shou
Organizational Affiliation
Shaanxi Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chengzhi Lu
Organizational Affiliation
Tianjin First Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xianhe Lin
Organizational Affiliation
The First Affiliated Hospital of Anhui Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zheng Zhang
Organizational Affiliation
LanZhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangjing Xie
Phone
13721053618
Email
xieyj2011@foxmail.com
Facility Name
The First Affiliated Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Zhang
Phone
13359401106
Email
783846183@qq.com
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiannan Dai
Phone
15124559838
Email
daijiannandr@163.com
Facility Name
Mudanjiang Cardiovascular Hospital
City
Mudanjiang
State/Province
Heilongjiang
ZIP/Postal Code
1570011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanqing Zhao
Phone
18946326812
Email
xingyunxing158@yeah.net
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohui Zheng
Phone
18838910817
Email
16859755@qq.com
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Bi
Phone
13971668450
Email
bisheng_123123@163.com
Facility Name
Shaanxi Provincial People's Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nier Zhong
Phone
13201790519
Email
zhongnier@sina.com
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
30001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyi Liu
Phone
18235123471
Email
Janeyiliu@163.com
Facility Name
Tianjin First Central Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300192
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dachuan Xia
Phone
13902061361
Email
xiadachuan@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29547992
Citation
Dai J, Xing L, Jia H, Zhu Y, Zhang S, Hu S, Lin L, Ma L, Liu H, Xu M, Ren X, Yu H, Li L, Zou Y, Zhang S, Mintz GS, Hou J, Yu B. In vivo predictors of plaque erosion in patients with ST-segment elevation myocardial infarction: a clinical, angiographical, and intravascular optical coherence tomography study. Eur Heart J. 2018 Jun 7;39(22):2077-2085. doi: 10.1093/eurheartj/ehy101.
Results Reference
background
Citation
2. The World Bank. Toward a healthy and harmonious life in China: stemming the rising tide of non-communicable diseases. http://www.worldbank.org/content/dam/Worldbank/document/NCD_ report_en.pdf (accessed Nov 27, 2013).
Results Reference
background
PubMed Identifier
24969506
Citation
Li J, Li X, Wang Q, Hu S, Wang Y, Masoudi FA, Spertus JA, Krumholz HM, Jiang L; China PEACE Collaborative Group. ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a retrospective analysis of hospital data. Lancet. 2015 Jan 31;385(9966):441-51. doi: 10.1016/S0140-6736(14)60921-1. Epub 2014 Jun 23.
Results Reference
background
PubMed Identifier
27056772
Citation
Stone GW, Selker HP, Thiele H, Patel MR, Udelson JE, Ohman EM, Maehara A, Eitel I, Granger CB, Jenkins PL, Nichols M, Ben-Yehuda O. Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol. 2016 Apr 12;67(14):1674-83. doi: 10.1016/j.jacc.2016.01.069.
Results Reference
background
PubMed Identifier
23536610
Citation
Frohlich GM, Meier P, White SK, Yellon DM, Hausenloy DJ. Myocardial reperfusion injury: looking beyond primary PCI. Eur Heart J. 2013 Jun;34(23):1714-22. doi: 10.1093/eurheartj/eht090. Epub 2013 Mar 27.
Results Reference
background
PubMed Identifier
32620851
Citation
Heusch G. Myocardial ischaemia-reperfusion injury and cardioprotection in perspective. Nat Rev Cardiol. 2020 Dec;17(12):773-789. doi: 10.1038/s41569-020-0403-y. Epub 2020 Jul 3.
Results Reference
background
PubMed Identifier
27118196
Citation
Hausenloy DJ, Botker HE, Engstrom T, Erlinge D, Heusch G, Ibanez B, Kloner RA, Ovize M, Yellon DM, Garcia-Dorado D. Targeting reperfusion injury in patients with ST-segment elevation myocardial infarction: trials and tribulations. Eur Heart J. 2017 Apr 1;38(13):935-941. doi: 10.1093/eurheartj/ehw145. No abstract available.
Results Reference
background
PubMed Identifier
24002794
Citation
Ibanez B, Macaya C, Sanchez-Brunete V, Pizarro G, Fernandez-Friera L, Mateos A, Fernandez-Ortiz A, Garcia-Ruiz JM, Garcia-Alvarez A, Iniguez A, Jimenez-Borreguero J, Lopez-Romero P, Fernandez-Jimenez R, Goicolea J, Ruiz-Mateos B, Bastante T, Arias M, Iglesias-Vazquez JA, Rodriguez MD, Escalera N, Acebal C, Cabrera JA, Valenciano J, Perez de Prado A, Fernandez-Campos MJ, Casado I, Garcia-Rubira JC, Garcia-Prieto J, Sanz-Rosa D, Cuellas C, Hernandez-Antolin R, Albarran A, Fernandez-Vazquez F, de la Torre-Hernandez JM, Pocock S, Sanz G, Fuster V. Effect of early metoprolol on infarct size in ST-segment-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention: the Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction (METOCARD-CNIC) trial. Circulation. 2013 Oct 1;128(14):1495-503. doi: 10.1161/CIRCULATIONAHA.113.003653. Epub 2013 Sep 3.
Results Reference
background
PubMed Identifier
27050189
Citation
Roolvink V, Ibanez B, Ottervanger JP, Pizarro G, van Royen N, Mateos A, Dambrink JE, Escalera N, Lipsic E, Albarran A, Fernandez-Ortiz A, Fernandez-Aviles F, Goicolea J, Botas J, Remkes W, Hernandez-Jaras V, Kedhi E, Zamorano JL, Navarro F, Alfonso F, Garcia-Lledo A, Alonso J, van Leeuwen M, Nijveldt R, Postma S, Kolkman E, Gosselink M, de Smet B, Rasoul S, Piek JJ, Fuster V, van 't Hof AWJ; EARLY-BAMI Investigators. Early Intravenous Beta-Blockers in Patients With ST-Segment Elevation Myocardial Infarction Before Primary Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016 Jun 14;67(23):2705-2715. doi: 10.1016/j.jacc.2016.03.522. Epub 2016 Apr 3.
Results Reference
background
PubMed Identifier
25240548
Citation
White SK, Frohlich GM, Sado DM, Maestrini V, Fontana M, Treibel TA, Tehrani S, Flett AS, Meier P, Ariti C, Davies JR, Moon JC, Yellon DM, Hausenloy DJ. Remote ischemic conditioning reduces myocardial infarct size and edema in patients with ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):178-188. doi: 10.1016/j.jcin.2014.05.015. Epub 2014 Sep 17.
Results Reference
background
PubMed Identifier
26385956
Citation
Eitel I, Stiermaier T, Rommel KP, Fuernau G, Sandri M, Mangner N, Linke A, Erbs S, Lurz P, Boudriot E, Mende M, Desch S, Schuler G, Thiele H. Cardioprotection by combined intrahospital remote ischaemic perconditioning and postconditioning in ST-elevation myocardial infarction: the randomized LIPSIA CONDITIONING trial. Eur Heart J. 2015 Nov 21;36(44):3049-57. doi: 10.1093/eurheartj/ehv463. Epub 2015 Sep 17.
Results Reference
background
PubMed Identifier
31500849
Citation
Hausenloy DJ, Kharbanda RK, Moller UK, Ramlall M, Aaroe J, Butler R, Bulluck H, Clayton T, Dana A, Dodd M, Engstrom T, Evans R, Lassen JF, Christensen EF, Garcia-Ruiz JM, Gorog DA, Hjort J, Houghton RF, Ibanez B, Knight R, Lippert FK, Lonborg JT, Maeng M, Milasinovic D, More R, Nicholas JM, Jensen LO, Perkins A, Radovanovic N, Rakhit RD, Ravkilde J, Ryding AD, Schmidt MR, Riddervold IS, Sorensen HT, Stankovic G, Varma M, Webb I, Terkelsen CJ, Greenwood JP, Yellon DM, Botker HE; CONDI-2/ERIC-PPCI Investigators. Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial. Lancet. 2019 Oct 19;394(10207):1415-1424. doi: 10.1016/S0140-6736(19)32039-2. Epub 2019 Sep 6.
Results Reference
background
PubMed Identifier
28886621
Citation
Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
Results Reference
background
PubMed Identifier
24315907
Citation
Hobl EL, Stimpfl T, Ebner J, Schoergenhofer C, Derhaschnig U, Sunder-Plassmann R, Jilma-Stohlawetz P, Mannhalter C, Posch M, Jilma B. Morphine decreases clopidogrel concentrations and effects: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2014 Feb 25;63(7):630-635. doi: 10.1016/j.jacc.2013.10.068. Epub 2013 Dec 4. Erratum In: J Am Coll Cardiol. 2018 Aug 7;72(6):705.
Results Reference
background
PubMed Identifier
27099137
Citation
Thomas MR, Morton AC, Hossain R, Chen B, Luo L, Shahari NN, Hua P, Beniston RG, Judge HM, Storey RF. Morphine delays the onset of action of prasugrel in patients with prior history of ST-elevation myocardial infarction. Thromb Haemost. 2016 Jul 4;116(1):96-102. doi: 10.1160/TH16-02-0102. Epub 2016 Apr 21.
Results Reference
background
PubMed Identifier
26491112
Citation
Kubica J, Adamski P, Ostrowska M, Sikora J, Kubica JM, Sroka WD, Stankowska K, Buszko K, Navarese EP, Jilma B, Siller-Matula JM, Marszall MP, Rosc D, Kozinski M. Morphine delays and attenuates ticagrelor exposure and action in patients with myocardial infarction: the randomized, double-blind, placebo-controlled IMPRESSION trial. Eur Heart J. 2016 Jan 14;37(3):245-52. doi: 10.1093/eurheartj/ehv547. Epub 2015 Oct 21.
Results Reference
background
PubMed Identifier
27420579
Citation
Bellandi B, Zocchi C, Xanthopoulou I, Scudiero F, Valenti R, Migliorini A, Antoniucci D, Marchionni N, Alexopoulos D, Parodi G. Morphine use and myocardial reperfusion in patients with acute myocardial infarction treated with primary PCI. Int J Cardiol. 2016 Oct 15;221:567-71. doi: 10.1016/j.ijcard.2016.06.204. Epub 2016 Jun 29. No abstract available.
Results Reference
background
PubMed Identifier
31976867
Citation
Furtado RHM, Nicolau JC, Guo J, Im K, White JA, Sabatine MS, Newby LK, Giugliano RP. Morphine and Cardiovascular Outcomes Among Patients With Non-ST-Segment Elevation Acute Coronary Syndromes Undergoing Coronary Angiography. J Am Coll Cardiol. 2020 Jan 28;75(3):289-300. doi: 10.1016/j.jacc.2019.11.035.
Results Reference
background
PubMed Identifier
26063213
Citation
Keating GM. Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting. Drugs. 2015 Jul;75(10):1119-30. doi: 10.1007/s40265-015-0419-5.
Results Reference
background
PubMed Identifier
19188334
Citation
Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.
Results Reference
background
PubMed Identifier
22436955
Citation
Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.
Results Reference
background
PubMed Identifier
27542303
Citation
Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
Results Reference
background
PubMed Identifier
30402501
Citation
Cheng X, Hu J, Wang Y, Ye H, Li X, Gao Q, Li Z. Effects of Dexmedetomidine Postconditioning on Myocardial Ischemia/Reperfusion Injury in Diabetic Rats: Role of the PI3K/Akt-Dependent Signaling Pathway. J Diabetes Res. 2018 Oct 8;2018:3071959. doi: 10.1155/2018/3071959. eCollection 2018.
Results Reference
background
PubMed Identifier
32406910
Citation
Zhang X, Li Y, Wang Y, Zhuang Y, Ren X, Yang K, Ma W, Zhong M. Dexmedetomidine postconditioning suppresses myocardial ischemia/reperfusion injury by activating the SIRT1/mTOR axis. Biosci Rep. 2020 May 29;40(5):BSR20194030. doi: 10.1042/BSR20194030.
Results Reference
background
PubMed Identifier
29328437
Citation
Weng X, Zhang X, Lu X, Wu J, Li S. Reduced mitochondrial response sensitivity is involved in the anti-apoptotic effect of dexmedetomidine pretreatment in cardiomyocytes. Int J Mol Med. 2018 Apr;41(4):2328-2338. doi: 10.3892/ijmm.2018.3384. Epub 2018 Jan 12.
Results Reference
background
PubMed Identifier
26607864
Citation
Riquelme JA, Westermeier F, Hall AR, Vicencio JM, Pedrozo Z, Ibacache M, Fuenzalida B, Sobrevia L, Davidson SM, Yellon DM, Sanchez G, Lavandero S. Dexmedetomidine protects the heart against ischemia-reperfusion injury by an endothelial eNOS/NO dependent mechanism. Pharmacol Res. 2016 Jan;103:318-27. doi: 10.1016/j.phrs.2015.11.004. Epub 2015 Dec 1.
Results Reference
background
PubMed Identifier
29359143
Citation
Gao JM, Meng XW, Zhang J, Chen WR, Xia F, Peng K, Ji FH. Dexmedetomidine Protects Cardiomyocytes against Hypoxia/Reoxygenation Injury by Suppressing TLR4-MyD88-NF-kappaB Signaling. Biomed Res Int. 2017;2017:1674613. doi: 10.1155/2017/1674613. Epub 2017 Nov 22.
Results Reference
background
PubMed Identifier
28914648
Citation
Yoshikawa Y, Hirata N, Kawaguchi R, Tokinaga Y, Yamakage M. Dexmedetomidine Maintains Its Direct Cardioprotective Effect Against Ischemia/Reperfusion Injury in Hypertensive Hypertrophied Myocardium. Anesth Analg. 2018 Feb;126(2):443-452. doi: 10.1213/ANE.0000000000002452.
Results Reference
background
PubMed Identifier
32407987
Citation
Chang JH, Jin MM, Liu JT. Dexmedetomidine pretreatment protects the heart against apoptosis in ischemia/reperfusion injury in diabetic rats by activating PI3K/Akt signaling in vivo and in vitro. Biomed Pharmacother. 2020 Jul;127:110188. doi: 10.1016/j.biopha.2020.110188. Epub 2020 May 11.
Results Reference
background
PubMed Identifier
30965239
Citation
He L, Hao S, Wang Y, Yang W, Liu L, Chen H, Qian J. Dexmedetomidine preconditioning attenuates ischemia/reperfusion injury in isolated rat hearts with endothelial dysfunction. Biomed Pharmacother. 2019 Jun;114:108837. doi: 10.1016/j.biopha.2019.108837. Epub 2019 Apr 6.
Results Reference
background
PubMed Identifier
28375904
Citation
Behmenburg F, Pickert E, Mathes A, Heinen A, Hollmann MW, Huhn R, Berger MM. The Cardioprotective Effect of Dexmedetomidine in Rats Is Dose-Dependent and Mediated by BKCa Channels. J Cardiovasc Pharmacol. 2017 Apr;69(4):228-235. doi: 10.1097/FJC.0000000000000466.
Results Reference
background
PubMed Identifier
31633505
Citation
Bunte S, Behmenburg F, Majewski N, Stroethoff M, Raupach A, Mathes A, Heinen A, Hollmann MW, Huhn R. Characteristics of Dexmedetomidine Postconditioning in the Field of Myocardial Ischemia-Reperfusion Injury. Anesth Analg. 2020 Jan;130(1):90-98. doi: 10.1213/ANE.0000000000004417.
Results Reference
background
PubMed Identifier
8623959
Citation
Lawrence CJ, Prinzen FW, de Lange S. The effect of dexmedetomidine on the balance of myocardial energy requirement and oxygen supply and demand. Anesth Analg. 1996 Mar;82(3):544-50. doi: 10.1097/00000539-199603000-00021.
Results Reference
background
PubMed Identifier
8949826
Citation
Roekaerts PM, Prinzen FW, De Lange S. Beneficial effects of dexmedetomidine on ischaemic myocardium of anaesthetized dogs. Br J Anaesth. 1996 Sep;77(3):427-9. doi: 10.1093/bja/77.3.427.
Results Reference
background
PubMed Identifier
12598239
Citation
Willigers HM, Prinzen FW, Roekaerts PM, de Lange S, Durieux ME. Dexmedetomidine decreases perioperative myocardial lactate release in dogs. Anesth Analg. 2003 Mar;96(3):657-664. doi: 10.1213/01.ANE.0000048708.75957.FF.
Results Reference
background
PubMed Identifier
22552015
Citation
Yoshitomi O, Cho S, Hara T, Shibata I, Maekawa T, Ureshino H, Sumikawa K. Direct protective effects of dexmedetomidine against myocardial ischemia-reperfusion injury in anesthetized pigs. Shock. 2012 Jul;38(1):92-7. doi: 10.1097/SHK.0b013e318254d3fb.
Results Reference
background
PubMed Identifier
26429360
Citation
Chi X, Liao M, Chen X, Zhao Y, Yang L, Luo A, Yang H. Dexmedetomidine Attenuates Myocardial Injury in Off-Pump Coronary Artery Bypass Graft Surgery. J Cardiothorac Vasc Anesth. 2016 Jan;30(1):44-50. doi: 10.1053/j.jvca.2015.06.026. Epub 2015 Jun 26.
Results Reference
background
PubMed Identifier
28182690
Citation
Li X, Yang J, Nie XL, Zhang Y, Li XY, Li LH, Wang DX, Ma D. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery: A randomized controlled trial. PLoS One. 2017 Feb 9;12(2):e0170757. doi: 10.1371/journal.pone.0170757. eCollection 2017.
Results Reference
background
PubMed Identifier
23513068
Citation
Ji F, Li Z, Nguyen H, Young N, Shi P, Fleming N, Liu H. Perioperative dexmedetomidine improves outcomes of cardiac surgery. Circulation. 2013 Apr 16;127(15):1576-84. doi: 10.1161/CIRCULATIONAHA.112.000936. Epub 2013 Mar 19.
Results Reference
background

Learn more about this trial

Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction

We'll reach out to this number within 24 hrs