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

Ischemic Reperfusion Injury Clinical Trial

— SCRIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02649309
• Other study ID #: PMK-SCRIP
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 2019

Study information

• Verified date: August 2018
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: Nakarin Sansanayudh, MD,PhD
• Phone: +6627639300
• Email: dr_nakarin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: July 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Reperfusion Injury
• Reperfusion Injury

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Internal Medicine	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiac Troponin-T from baseline		within 24 hours
Secondary	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
Secondary	Major adverse cardiovascular events (MACE) in each intervention group	MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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