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

Primary Purpose

Ischemic Reperfusion Injury

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
RIPre
Sham-Pre
RIPost
Sham-Post
Sponsored by
Phramongkutklao College of Medicine and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Reperfusion Injury focused on measuring Ischemic Preconditioning, Postconditioning, Angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

RIPre + RIPost

RIPre + Sham

Sham + RIPost

Sham + Sham

Arm Description

Intervention: RIPre 200 mmHg + RIPost 200 mmHg

Intervention: RIPre 200 mmHg + Sham 10 mmHg

Intervention: Sham 10 mmHg + RIPost 200 mmHg

Intervention: Sham 10 mmHg + Sham 10 mmHg

Outcomes

Primary Outcome Measures

Change in cardiac Troponin-T from baseline

Secondary Outcome Measures

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).
Major adverse cardiovascular events (MACE) in each intervention group
MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
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).
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).
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.
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.
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).

Full Information

First Posted
December 1, 2015
Last Updated
August 28, 2018
Sponsor
Phramongkutklao College of Medicine and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02649309
Brief Title
Single-cycle Remote Ischemic Preconditioning and Postconditioning (SCRIP) Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Reperfusion Injury
Keywords
Ischemic Preconditioning, Postconditioning, Angioplasty

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIPre + RIPost
Arm Type
Experimental
Arm Description
Intervention: RIPre 200 mmHg + RIPost 200 mmHg
Arm Title
RIPre + Sham
Arm Type
Experimental
Arm Description
Intervention: RIPre 200 mmHg + Sham 10 mmHg
Arm Title
Sham + RIPost
Arm Type
Experimental
Arm Description
Intervention: Sham 10 mmHg + RIPost 200 mmHg
Arm Title
Sham + Sham
Arm Type
Sham Comparator
Arm Description
Intervention: Sham 10 mmHg + Sham 10 mmHg
Intervention Type
Procedure
Intervention Name(s)
RIPre
Intervention Description
Preconditioning 200 mmHg x 5 minutes before procedure
Intervention Type
Procedure
Intervention Name(s)
Sham-Pre
Intervention Description
Sham 10 mmHg x 5 minutes before procedure
Intervention Type
Procedure
Intervention Name(s)
RIPost
Intervention Description
Postconditioning 200 mmHg x 5 minutes after procedure
Intervention Type
Procedure
Intervention Name(s)
Sham-Post
Intervention Description
Sham 10 mmHg x 5 minutes after procedure
Primary Outcome Measure Information:
Title
Change in cardiac Troponin-T from baseline
Time Frame
within 24 hours
Secondary Outcome Measure Information:
Title
Incidence of myocardial injury
Description
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).
Time Frame
within 24 hours
Title
Major adverse cardiovascular events (MACE) in each intervention group
Description
MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
Time Frame
6 months
Title
Incidence of myocardial injury in differrent subgroups of patient characteristics
Description
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).
Time Frame
within 24 hours
Title
Incidence of myocardial injury in patients with vs. without RIPre and RIPost
Description
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).
Time Frame
24 hours
Title
Incidence of MACE in differrent subgroups of patient characteristics
Description
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.
Time Frame
6 months
Title
Incidence of MACE in patients with vs. without RIPre and RIPost
Description
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.
Time Frame
6 months
Title
Incidence of MACE in patients who have myocardial injury vs. patients who have no myocardial injury
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nakarin Sansanayudh, MD,PhD
Phone
+6627639300
Ext
93807
Email
dr_nakarin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kitcha Champasri, MD
Phone
+66897146999
Email
dr.kitcha@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nakarin Sansanayudh, MD,PhD
Organizational Affiliation
Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nakarin Sansanayudh, MD,PhD
Phone
+6623547600
Ext
93827
Email
dr_nakarin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Kitcha Champasri, MD
Phone
+66897146969
Email
dr.kitcha@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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