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Effect of Perioperative Ultrasound-guided Remote Ischemic Conditioning on Acute Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ultrasound-guided remote ischemic conditioning
Traditional remote ischemic conditioning
Percutaneous coronary intervention
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Remote ischemic conditioning, Percutaneous coronary intervention, Infarction, Myocardial injury, Acute myocardial infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Newly developed ST segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (non-STEMI) according to clinical symptoms, ECG and laboratory confirmation;
  2. Patients aged 18-80 yr;
  3. Scheduled for PCI;
  4. With normal cognitive function indicated by MMSE score >16 and able to cooperate with intervention;
  5. Agreed to participate and signed the consent form.

Exclusion Criteria:

  1. Previous STEMI or non-STEMI;
  2. Previous coronary artery bypass grafting (CABG) ;
  3. Developed thrombolysis within the last 30 days;
  4. Cardiogenic shock history;
  5. Persistent atrial fibrillation history;
  6. Severe complications (e.g. ventricular septal rupture, free wall rupture or acute severe mitral regurgitation) warrant surgical interventions;
  7. Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg);
  8. With peripheral neuropathy, peripheral artery disease, superficial thrombophlebitis or deep vein thrombosis;
  9. Other severe systemic diseases;
  10. Participated in other trials previously.

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Ultrasound-guided-RIC group

Traditional RIC group

Control group

Arm Description

Patients in the ultrasound-guided-RIC group will receive percutaneous coronary intervention (PCI), usual pharmacotherapy and pre-, per-, and post-operative ultrasound-guided remote ischemic conditioning (RIC). The pressure applied during cuff inflation is total occlusion pressure (TOP) determined with ultrasound measurement.

Patients in the traditional RIC group will receive PCI, usual pharmacotherapy and pre-, per-, and post-operative traditional RIC. The pressure applied during cuff inflation is 20 mmHg above systolic blood pressure.

Patients in the control group will receive PCI and usual pharmacotherapy.

Outcomes

Primary Outcome Measures

Infarct size
Cardiac enzyme infarct size is assessed as 72-hour area under the curve (AUC) cardiac troponin T (cTnT) release.

Secondary Outcome Measures

Plasma concentration of myocardial infarction-related key biomarkers (PCMIKB)
PCMIKB will be reflected with concentration of cardiac troponin T (cTnT).
B-type natriuretic peptide (BNP)
The concentration of BNP will be measured during perioperative period.
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF) will be measured with two dimensional echocardiography.
Left ventricular end-diastolic volume (LVEDV)
Left ventricular end-diastolic volume (LVEDV) will be measured with two dimensional echocardiography.
Left ventricular end systolic volume (LVESV).
Left ventricular end systolic volume (LVESV) will be measured with two dimensional echocardiography.
Cardiopulmonary endurance
Cardiopulmonary endurance will be measured with the 6-min walking test (6MWT).
Blood pressure
Systolic and diastolic blood pressure will be monitored before and after training.
Heart rate
Heart rate will be monitored before and after training.
Total hospital length of stay (LOS)
LOS accounts for total hospital LOS in both acute hospital and rehabilitation hospital after PCI.

Full Information

First Posted
September 1, 2021
Last Updated
November 10, 2021
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05044806
Brief Title
Effect of Perioperative Ultrasound-guided Remote Ischemic Conditioning on Acute Myocardial Infarction
Official Title
Effect of Perioperative Ultrasound-guided Remote Ischemic Conditioning on Myocardial Injury in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention: a Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 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
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acute myocardial infarction (AMI) is an event of myocardial necrosis caused by myocardial ischemia. Although the incidence and economic burden of AMI has declined in high-income countries, the incidence rate of AMI in China has increased dramatically over the past several decades. Initial medical therapy combined with primary percutaneous coronary intervention (PCI) is currently the most important advance in restoring coronary perfusion. Timely reperfusion therapy may halt the progress of necrosis and preserve viable tissue; however, it can also induce myocardial injury and cause cardiomyocyte death, a phenomenon called myocardial ischemia reperfusion injury (IRI), which can increase final myocardial infarct size by up to 50%. Unfortunately, there is no effective intervention for preventing IRI to date, though an improved understanding of the pathophysiology of IRI has led to the suggestion of several innovative therapeutic strategies with the potential for reducing unintended negative side effects of reperfusion therapy in AMI patients. Whether there is a therapeutic intervention that can effectively and safely reduce myocardial infarct size and cardiac mortality has been intensely explored over the years. Against this backdrop, a phenomenon called remote ischemic conditioning (RIC) has long been discussed as a potential approach to address the above issues. The purpose of present study is to investigate the efficacy of perioperative remote ischemic conditioning delivered at individual timepoints (e.g., pre-, per- and post-PCI) on myocardial injury in patients with AMI.
Detailed Description
RIC refers to a cardio-protective effect induced by non-invasively applying cycles of physiological ischemia and reperfusion to remote body parts, e.g., through application of a blood pressure cuff or similar device to a remote limb. The actual molecular biological mechanisms underlying RIC may be attributed to a neuro-hormonal pathway conveying a cardio-protective signal from a local limb to the remote heart. The safety of RIC delivered at a single time point (e.g., pre-, per- or post-PCI) in AMI patients has been well established in a number of clinical trials. However, the RIC's cardio-protective effects remain under debate, especially for RIC programs delivered at individual timepoints during operative period (pre-, per- and post-PCI). Besides, in these trials, the cuff compression pressure of RIC protocol is mostly 200mmHg or 20-50mmHg above systolic pressure. Peripheral vascular ischemia effects of upper limbs are different under different pressure conditions. However, no study has been conducted to investigate the clinical effects of RIC training under different pressure conditions. In the present study, ultrasound is used to determine the brachial artery total occlusion pressure (TOP), which is regarded as optimal pressure of flow restriction in ischemic exercise training. And patients in the ultrasound-guided RIC group will receive RIC applying TOP as cuff compression pressure, while compression pressure applied in traditional RIC group patients is 20mmHg above systolic pressure. The purpose of present study is to investigate the effect of perioperative RIC delivered across the full disease cycle, and compare the effects of ultrasound-guided RIC protocol and traditional RIC protocol on cardiac enzyme infarct size, cardiac function, cardiopulmonary endurance and quality of life in patients with AMI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Remote ischemic conditioning, Percutaneous coronary intervention, Infarction, Myocardial injury, Acute myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided-RIC group
Arm Type
Experimental
Arm Description
Patients in the ultrasound-guided-RIC group will receive percutaneous coronary intervention (PCI), usual pharmacotherapy and pre-, per-, and post-operative ultrasound-guided remote ischemic conditioning (RIC). The pressure applied during cuff inflation is total occlusion pressure (TOP) determined with ultrasound measurement.
Arm Title
Traditional RIC group
Arm Type
Experimental
Arm Description
Patients in the traditional RIC group will receive PCI, usual pharmacotherapy and pre-, per-, and post-operative traditional RIC. The pressure applied during cuff inflation is 20 mmHg above systolic blood pressure.
Arm Title
Control group
Arm Type
Other
Arm Description
Patients in the control group will receive PCI and usual pharmacotherapy.
Intervention Type
Other
Intervention Name(s)
Ultrasound-guided remote ischemic conditioning
Intervention Description
Before conducting RIC, Doppler ultrasound was used to measure the total occlusion pressure (TOP) of brachial artery, which was then determined as the cuff inflation pressure during RIC. The RIC program encompasses four main components of (1) three cycles of remote ischemic pre-conditioning which will be delivered right after the eligibility check and informed consent form signature before PCI; (2) one cycle of remote ischemic per-conditioning, which will be delivered during PCI; (3) three cycles of remote ischemic post-conditioning, which will be delivered within 10 min after PCI; and (4) two sessions per day of remote ischemic post-conditioning which will start on post-operative day 1 and last till hospital discharge. The remote ischemic pre- and post-conditioning share the RIC protocol, which comprises three 3 min cycles of RIC with 3 min intervals of reperfusion in between, while only one single 3 min cycle will be delivered for the remote ischemic per-conditioning.
Intervention Type
Other
Intervention Name(s)
Traditional remote ischemic conditioning
Intervention Description
The RIC program encompasses four main components of (1)three cycles of remote ischemic pre-conditioning which will be delivered right after the eligibility check and informed consent form signature before PCI; (2)one cycle of remote ischemic per-conditioning, which will be delivered during PCI; (3)three cycles of remote ischemic post-conditioning, which will be delivered within 10 min after PCI; and (4) two sessions per day of remote ischemic post-conditioning which will start on post-operative day 1 and last till hospital discharge. The remote ischemic pre- and post-conditioning share the RIC protocol, which comprises three 3 min cycles of upper limb ischemia on the arm that is opposite to the PCI side with 3 min intervals of reperfusion in between delivered by an automated cuff inflation/deflation device, while only one single 3 min cycle will be delivered for the remote ischemic per-conditioning. The pressure applied during cuff inflation is 20 mmHg above systolic blood pressure.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Other Intervention Name(s)
coronary angioplasty
Intervention Description
Percutaneous coronary intervention (PCI) will be performed by a cardiologist or doctor who specializes in the heart to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque. PCI requires cardiac catheterization, which is the insertion of a catheter tube, and live x rays helping to guide the catheter into the heart to inject special contrast dye that will highlight the blockage. To open a blocked artery, another catheter will be inserted over a guidewire, a balloon will be inflated at the tip of that catheter, and a small mesh tube called a stent may be put in the artery to help keep the artery open. After PCI, the catheters will be removed, the opening on the wrist or groin will be closed and bandaged.
Primary Outcome Measure Information:
Title
Infarct size
Description
Cardiac enzyme infarct size is assessed as 72-hour area under the curve (AUC) cardiac troponin T (cTnT) release.
Time Frame
During 0-72 hours after surgery
Secondary Outcome Measure Information:
Title
Plasma concentration of myocardial infarction-related key biomarkers (PCMIKB)
Description
PCMIKB will be reflected with concentration of cardiac troponin T (cTnT).
Time Frame
Three days after surgery
Title
B-type natriuretic peptide (BNP)
Description
The concentration of BNP will be measured during perioperative period.
Time Frame
Three days after surgery
Title
Left ventricular ejection fraction (LVEF)
Description
Left ventricular ejection fraction (LVEF) will be measured with two dimensional echocardiography.
Time Frame
One week after surgery
Title
Left ventricular end-diastolic volume (LVEDV)
Description
Left ventricular end-diastolic volume (LVEDV) will be measured with two dimensional echocardiography.
Time Frame
One week after surgery
Title
Left ventricular end systolic volume (LVESV).
Description
Left ventricular end systolic volume (LVESV) will be measured with two dimensional echocardiography.
Time Frame
One week after surgery
Title
Cardiopulmonary endurance
Description
Cardiopulmonary endurance will be measured with the 6-min walking test (6MWT).
Time Frame
Three days after surgery
Title
Blood pressure
Description
Systolic and diastolic blood pressure will be monitored before and after training.
Time Frame
When postoperative RIC is finished(within 10 minutes after PCI)
Title
Heart rate
Description
Heart rate will be monitored before and after training.
Time Frame
When postoperative RIC is finished(within 10 minutes after PCI)
Title
Total hospital length of stay (LOS)
Description
LOS accounts for total hospital LOS in both acute hospital and rehabilitation hospital after PCI.
Time Frame
Up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly developed ST segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (non-STEMI) according to clinical symptoms, ECG and laboratory confirmation; Patients aged 18-80 yr; Scheduled for PCI; With normal cognitive function indicated by MMSE score >16 and able to cooperate with intervention; Agreed to participate and signed the consent form. Exclusion Criteria: Previous STEMI or non-STEMI; Previous coronary artery bypass grafting (CABG) ; Developed thrombolysis within the last 30 days; Cardiogenic shock history; Persistent atrial fibrillation history; Severe complications (e.g. ventricular septal rupture, free wall rupture or acute severe mitral regurgitation) warrant surgical interventions; Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg); With peripheral neuropathy, peripheral artery disease, superficial thrombophlebitis or deep vein thrombosis; Other severe systemic diseases; Participated in other trials previously.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Zheng, M.D.
Phone
+86 17327081766
Email
zhengyu8710@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Lu, M.D.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Zheng, M.D.
Phone
86 17327081766
Email
zhengyu8710@163.com
First Name & Middle Initial & Last Name & Degree
Xiao Lu
First Name & Middle Initial & Last Name & Degree
Yu Zheng
First Name & Middle Initial & Last Name & Degree
Liang Yuan
First Name & Middle Initial & Last Name & Degree
Dijia Pan
First Name & Middle Initial & Last Name & Degree
Xintong Zhang
First Name & Middle Initial & Last Name & Degree
Xiu Zhang
First Name & Middle Initial & Last Name & Degree
Qiuyu Yu

12. IPD Sharing Statement

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Effect of Perioperative Ultrasound-guided Remote Ischemic Conditioning on Acute Myocardial Infarction

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