Single-cycle Remote Ischemic Preconditioning and Postconditioning (SCRIP) Trial

Overview

This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in patient undergoing coronary angioplasty.

Full Title of Study: “Effect of Single-cycle Remote Ischemic Preconditioning and Postconditioning on Myocardial Injury in Patients Undergoing Emergency and Elective Percutaneous Intervention in Phramongkutklao Hospital and Thammasat University”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2019

Interventions

  • Procedure: RIPre
    • Preconditioning 200 mmHg x 5 minutes before procedure
  • Procedure: Sham-Pre
    • Sham 10 mmHg x 5 minutes before procedure
  • Procedure: RIPost
    • Postconditioning 200 mmHg x 5 minutes after procedure
  • Procedure: Sham-Post
    • Sham 10 mmHg x 5 minutes after procedure

Arms, Groups and Cohorts

  • Experimental: RIPre + RIPost
    • Intervention: RIPre 200 mmHg + RIPost 200 mmHg
  • Experimental: RIPre + Sham
    • Intervention: RIPre 200 mmHg + Sham 10 mmHg
  • Experimental: Sham + RIPost
    • Intervention: Sham 10 mmHg + RIPost 200 mmHg
  • Sham Comparator: Sham + Sham
    • Intervention: Sham 10 mmHg + Sham 10 mmHg

Clinical Trial Outcome Measures

Primary Measures

  • Change in cardiac Troponin-T from baseline
    • Time Frame: within 24 hours

Secondary Measures

  • Incidence of myocardial injury
    • Time Frame: within 24 hours
    • Incidence of myocardial injury defined as > 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin > 20% in patients who have elevated baseline troponin (>99 percentile upper reference limit).
  • Major adverse cardiovascular events (MACE) in each intervention group
    • Time Frame: 6 months
    • MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
  • Incidence of myocardial injury in differrent subgroups of patient characteristics
    • Time Frame: within 24 hours
    • Patient characteristics include sex, age, underlying disease, medications, indication for PCI (ACS and elective PCI), baseline cardiac enzyme and creatinine. Incidence of myocardial injury defined as > 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin > 20% in patients who have elevated baseline troponin (>99 percentile upper reference limit).
  • Incidence of myocardial injury in patients with vs. without RIPre and RIPost
    • Time Frame: 24 hours
    • Myocardial injury defined as > 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin > 20% in patients who have elevated baseline troponin (>99 percentile upper reference limit).
  • Incidence of MACE in differrent subgroups of patient characteristics
    • Time Frame: 6 months
    • Patient characteristics include sex, age, underlying disease, medications, indication for PCI (ACS and elective PCI), baseline cardiac enzyme and creatinine. MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
  • Incidence of MACE in patients with vs. without RIPre and RIPost
    • Time Frame: 6 months
    • Patient characteristics include sex, age, underlying disease, medications, indication for PCI (ACS and elective PCI), baseline cardiac enzyme and creatinine. MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
  • Incidence of MACE in patients who have myocardial injury vs. patients who have no myocardial injury
    • Time Frame: 6 months
    • Myocardial injury defined as > 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin > 20% in patients who have elevated baseline troponin (>99 percentile upper reference limit).

Participating in This Clinical Trial

Inclusion Criteria

  • Eligible for percutaneous coronary intervention (elective and emergency cases)
  • Age > 18-year-old
  • Informed consent

Exclusion Criteria

  • Previous CABG
  • Previous PCI in 1 week / treatment with thrombolysis within 30 days
  • Peripheral arterial disease / A-V shunt of upper extremities (AVF for hemodialysis)
  • Paresis of upper limb
  • Unstable patient such as cardiogenic shock / vasopressor / IABP / cooling (hypothermia)
  • Fatal cardiac arrhythmia (VT / VF)
  • Chronic hypoxia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Phramongkutklao College of Medicine and Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nakarin Sansanayudh, MD,PhD, Principal Investigator, Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand
  • Overall Contact(s)
    • Nakarin Sansanayudh, MD,PhD, +6627639300, dr_nakarin@hotmail.com

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