Single-cycle Remote Ischemic Preconditioning and Postconditioning (SCRIP) Trial
SCRIP
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
1 other identifier
interventional
370
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedAugust 31, 2018
August 1, 2018
3.6 years
December 1, 2015
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in cardiac Troponin-T from baseline
within 24 hours
Secondary Outcomes (7)
Incidence of myocardial injury
within 24 hours
Major adverse cardiovascular events (MACE) in each intervention group
6 months
Incidence of myocardial injury in differrent subgroups of patient characteristics
within 24 hours
Incidence of myocardial injury in patients with vs. without RIPre and RIPost
24 hours
Incidence of MACE in differrent subgroups of patient characteristics
6 months
- +2 more secondary outcomes
Study Arms (4)
RIPre + RIPost
EXPERIMENTALIntervention: RIPre 200 mmHg + RIPost 200 mmHg
RIPre + Sham
EXPERIMENTALIntervention: RIPre 200 mmHg + Sham 10 mmHg
Sham + RIPost
EXPERIMENTALIntervention: Sham 10 mmHg + RIPost 200 mmHg
Sham + Sham
SHAM COMPARATORIntervention: Sham 10 mmHg + Sham 10 mmHg
Interventions
Eligibility Criteria
You may qualify if:
- Eligible for percutaneous coronary intervention (elective and emergency cases)
- Age \> 18-year-old
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine
Bangkok, 10400, Thailand
Study Officials
- PRINCIPAL INVESTIGATOR
Nakarin Sansanayudh, MD,PhD
Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2015
First Posted
January 7, 2016
Study Start
October 1, 2015
Primary Completion
May 1, 2019
Study Completion
July 1, 2019
Last Updated
August 31, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share