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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ischemic Reperfusion Injury

Intervention / Treatment
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* Procedure: RIPre
* Procedure: Sham-Pre
* Procedure: RIPost
* Procedure: Sham-Post


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPre + RIPost<br>Intervention: RIPre 200 mmHg + RIPost 200 mmHg | Procedure: RIPre<br>* Preconditioning 200 mmHg x 5 minutes before procedure<br>Procedure: RIPost<br>* Postconditioning 200 mmHg x 5 minutes after procedure<br>|
| Experimental: RIPre + Sham<br>Intervention: RIPre 200 mmHg + Sham 10 mmHg | Procedure: RIPre<br>* Preconditioning 200 mmHg x 5 minutes before procedure<br>Procedure: Sham-Post<br>* Sham 10 mmHg x 5 minutes after procedure<br>|
| Experimental: Sham + RIPost<br>Intervention: Sham 10 mmHg + RIPost 200 mmHg | Procedure: Sham-Pre<br>* Sham 10 mmHg x 5 minutes before procedure<br>Procedure: RIPost<br>* Postconditioning 200 mmHg x 5 minutes after procedure<br>|
| Sham Comparator: Sham + Sham<br>Intervention: Sham 10 mmHg + Sham 10 mmHg | Procedure: Sham-Pre<br>* Sham 10 mmHg x 5 minutes before procedure<br>Procedure: Sham-Post<br>* Sham 10 mmHg x 5 minutes after procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac Troponin-T from baseline |  | within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of myocardial injury | 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). | within 24 hours | 
| Major adverse cardiovascular events (MACE) in each intervention group | MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure. | 6 months | 
| Incidence of myocardial injury in differrent subgroups of patient characteristics | 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). | within 24 hours | 
| Incidence of myocardial injury in patients with vs. without RIPre and RIPost | 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). | 24 hours | 
| Incidence of MACE in differrent subgroups of patient characteristics | 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. | 6 months | 
| Incidence of MACE in patients with vs. without RIPre and RIPost | 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. | 6 months | 
| Incidence of MACE in patients who have myocardial injury vs. patients who have no myocardial injury | 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). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Preconditioning, Postconditioning, Angioplasty