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

Not Applicable

• Conditions: Ischemic Reperfusion Injury
• Interventions: Procedure: RIPre; Procedure: Sham-Pre; Procedure: RIPost; Procedure: Sham-Post

• Registration Number: NCT02649309
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31
• Primary Completion: 2019-05
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 370

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
RIPre + RIPost	RIPost	Intervention: RIPre 200 mmHg + RIPost 200 mmHg
RIPre + Sham	RIPre	Intervention: RIPre 200 mmHg + Sham 10 mmHg
Sham + Sham	Sham-Post	Intervention: Sham 10 mmHg + Sham 10 mmHg
RIPre + RIPost	RIPre	Intervention: RIPre 200 mmHg + RIPost 200 mmHg
RIPre + Sham	Sham-Post	Intervention: RIPre 200 mmHg + Sham 10 mmHg
Sham + RIPost	Sham-Pre	Intervention: Sham 10 mmHg + RIPost 200 mmHg
Sham + RIPost	RIPost	Intervention: Sham 10 mmHg + RIPost 200 mmHg
Sham + Sham	Sham-Pre	Intervention: Sham 10 mmHg + Sham 10 mmHg

Primary Outcome Measures

Name	Time	Method
Change in cardiac Troponin-T from baseline	within 24 hours

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events (MACE) in each intervention group	6 months	MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
Incidence of myocardial injury	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).
Incidence of myocardial injury in differrent subgroups of patient characteristics	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 MACE in differrent subgroups of patient characteristics	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	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	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).
Incidence of myocardial injury in patients with vs. without RIPre and RIPost	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).

Trial Locations

Locations (1)

Department of Internal Medicine; 🇹🇭 Bangkok, Thailand