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Effect of Nicorandil on Cardiac Sympathetic Nerve for the Patients of Acute ST Segment Elevation Myocardial Infarction

Primary Purpose

Coronary Heart Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
nicorandil
Placebo(normal saline)
Sponsored by
Xuzhou Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease focused on measuring nicorandil, primary percutaneous coronary intervention, acute ST segment elevation myocardial infarction, cardiac sympathetic nerve

Eligibility Criteria

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

Inclusion Criteria:

  1. acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;
  2. Age20-80,All genders
  3. anterior myocardial infarction
  4. The first myocardial infarction
  5. The infarct-related artery(IRA) is totally occlusive
  6. Blood pressure is higher than 90/60 millimeters of mercury(mmHg)
  7. The time from myocardial infarction onset to reach the hospital is less than 12 hs

Exclusion Criteria:

  1. kidney dysfunction (creatinine >2 mg/dl),
  2. History of previous liver disease,
  3. Cardiogenic shock,
  4. History of myocardial infarction (MI)
  5. History of coronary artery bypass grafting
  6. History of allergic response to drugs
  7. Severe hypovolemia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Nicorandil

    Placebo (normal saline)

    Arm Description

    Patients who received intracoronary and intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention

    Patients who received intracoronary and intravenous placebo before and after reperfusion with primary percutaneous coronary intervention

    Outcomes

    Primary Outcome Measures

    Comparison of the delayed heart/mediastinum count (H/M) ratio
    The delayed heart/mediastinum count (H/M) ratio was determined from 123I-meta-iodobenzylguanidine (MIBG) images

    Secondary Outcome Measures

    The total defect score (TDS)
    The total defect score was determined from 123I-meta-iodobenzylguanidine (MIBG) images
    Rate of slow re-flow/no-reflow phenomenon
    TIMI myocardial perfusion grade (TMPG) of the final coronary flow in the culprit artery
    Rate fo complete ST-segment resolution
    ST-segment resolution >50 percent in ECG
    Rate of unplanned hospitalization for heart failure
    Rate of unplanned hospitalization for heart failure
    The washout rate (WR)
    The washout rate (WR) were determined from 123I-meta-iodobenzylguanidine (MIBG) images
    The total defect score (TDS)
    The total defect score was determined from 99mTc-pyrophosphate scintigraphy

    Full Information

    First Posted
    March 23, 2021
    Last Updated
    March 31, 2021
    Sponsor
    Xuzhou Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04826497
    Brief Title
    Effect of Nicorandil on Cardiac Sympathetic Nerve for the Patients of Acute ST Segment Elevation Myocardial Infarction
    Official Title
    Effects of Nicorandil on Cardiac Sympathetic Nerve Activity and Distribution in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xuzhou Central Hospital

    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
    The investigators evaluate the effects of intracoronary and intravenous administration of nicorandil on cardiac sympathetic nerve activity and distribution in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention
    Detailed Description
    Reperfusion injury might occur in patients with acute ST segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(P-PCI),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and injury of cardiac sympathetic nerve, etc. Nicorandil is an antianginal agent with a dual mechanism of action: nitrate and K+ATP channel opener. The nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (ATP)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. Nicorandil not only decreases preload and afterload but also increases coronary blood flow. The study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury especially injury of cardiac sympathetic nerve in patients with acute ST segment elevation myocardial infarction undergoing the P-PCI.It is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation,moreover,it could reduces the release of norepinephrine from sympathetic endings of the heart directly.So,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and injury of cardiac sympathetic nerve.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Heart Disease
    Keywords
    nicorandil, primary percutaneous coronary intervention, acute ST segment elevation myocardial infarction, cardiac sympathetic nerve

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nicorandil
    Arm Type
    Experimental
    Arm Description
    Patients who received intracoronary and intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention
    Arm Title
    Placebo (normal saline)
    Arm Type
    Placebo Comparator
    Arm Description
    Patients who received intracoronary and intravenous placebo before and after reperfusion with primary percutaneous coronary intervention
    Intervention Type
    Drug
    Intervention Name(s)
    nicorandil
    Other Intervention Name(s)
    Experiment Group
    Intervention Description
    All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg nicorandil was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo(normal saline)
    Other Intervention Name(s)
    Control Group
    Intervention Description
    All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg placebo was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of placebo to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention
    Primary Outcome Measure Information:
    Title
    Comparison of the delayed heart/mediastinum count (H/M) ratio
    Description
    The delayed heart/mediastinum count (H/M) ratio was determined from 123I-meta-iodobenzylguanidine (MIBG) images
    Time Frame
    10 days after primary PCI
    Secondary Outcome Measure Information:
    Title
    The total defect score (TDS)
    Description
    The total defect score was determined from 123I-meta-iodobenzylguanidine (MIBG) images
    Time Frame
    10 days after primary PCI
    Title
    Rate of slow re-flow/no-reflow phenomenon
    Description
    TIMI myocardial perfusion grade (TMPG) of the final coronary flow in the culprit artery
    Time Frame
    5 minutes after primary PCI
    Title
    Rate fo complete ST-segment resolution
    Description
    ST-segment resolution >50 percent in ECG
    Time Frame
    2 hours after primary PCI
    Title
    Rate of unplanned hospitalization for heart failure
    Description
    Rate of unplanned hospitalization for heart failure
    Time Frame
    6 months after primary PCI
    Title
    The washout rate (WR)
    Description
    The washout rate (WR) were determined from 123I-meta-iodobenzylguanidine (MIBG) images
    Time Frame
    10 days after primary PCI
    Title
    The total defect score (TDS)
    Description
    The total defect score was determined from 99mTc-pyrophosphate scintigraphy
    Time Frame
    7 days after primary PCI

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: acute ST-segment elevation myocardial infarction within 12 hours of symptom onset; Age20-80,All genders anterior myocardial infarction The first myocardial infarction The infarct-related artery(IRA) is totally occlusive Blood pressure is higher than 90/60 millimeters of mercury(mmHg) The time from myocardial infarction onset to reach the hospital is less than 12 hs Exclusion Criteria: kidney dysfunction (creatinine >2 mg/dl), History of previous liver disease, Cardiogenic shock, History of myocardial infarction (MI) History of coronary artery bypass grafting History of allergic response to drugs Severe hypovolemia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    chunguang Feng, PhD
    Phone
    +8618936376559
    Email
    fcg999@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Institute of Cardiovascular Disease Xuzhou Central Hospital
    Organizational Affiliation
    Southeast University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    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
    result
    PubMed Identifier
    12607706
    Citation
    Piper HM, Meuter K, Schafer C. Cellular mechanisms of ischemia-reperfusion injury. Ann Thorac Surg. 2003 Feb;75(2):S644-8. doi: 10.1016/s0003-4975(02)04686-6.
    Results Reference
    result
    PubMed Identifier
    31147987
    Citation
    Ji Z, Zhang R, Lu W, Ma G, Qu Y. The effect of nicorandil in patients with acute myocardial infarction undergoing percutaneous coronary intervention: a systematic review and meta-analysis. Ir J Med Sci. 2020 Feb;189(1):119-131. doi: 10.1007/s11845-019-02034-3. Epub 2019 May 30.
    Results Reference
    result
    PubMed Identifier
    31118574
    Citation
    Xu L, Wang L, Li K, Zhang Z, Sun H, Yang X. Nicorandil prior to primary percutaneous coronary intervention improves clinical outcomes in patients with acute myocardial infarction: a meta-analysis of randomized controlled trials. Drug Des Devel Ther. 2019 Apr 29;13:1389-1400. doi: 10.2147/DDDT.S195918. eCollection 2019.
    Results Reference
    result
    PubMed Identifier
    28966311
    Citation
    Fukui Y, Nozawa T, Ihori H, Sobajima M, Nakadate T, Matsuki A, Nonomura M, Fujii N, Inoue H, Kinugawa K. Nicorandil Attenuates Ischemia-Reperfusion Injury Via Inhibition of Norepinephrine Release From Cardiac Sympathetic Nerve Terminals. Int Heart J. 2017 Oct 21;58(5):787-793. doi: 10.1536/ihj.16-391. Epub 2017 Sep 30.
    Results Reference
    result
    PubMed Identifier
    15791442
    Citation
    Kasama S, Toyama T, Kumakura H, Takayama Y, Ichikawa S, Suzuki T, Kurabayashi M. Effects of nicorandil on cardiac sympathetic nerve activity after reperfusion therapy in patients with first anterior acute myocardial infarction. Eur J Nucl Med Mol Imaging. 2005 Mar;32(3):322-8. doi: 10.1007/s00259-004-1672-0. Epub 2004 Oct 2.
    Results Reference
    result
    PubMed Identifier
    29495982
    Citation
    Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048.
    Results Reference
    result

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    Effect of Nicorandil on Cardiac Sympathetic Nerve for the Patients of Acute ST Segment Elevation Myocardial Infarction

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