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

August 28, 2018 updated by: Phramongkutklao College of Medicine and Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

370

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Department of Internal Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
within 24 hours
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.
6 months
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).
within 24 hours
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).
24 hours
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.
6 months
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.
6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phramongkutklao College of Medicine and Hospital

Investigators

  • Principal Investigator: Nakarin Sansanayudh, MD,PhD, Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMK-SCRIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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