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

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ClinicalTrials.gov Identifier: NCT02649309
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ischemic Reperfusion Injury Procedure: RIPre Procedure: Sham-Pre Procedure: RIPost Procedure: Sham-Post Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : October 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

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: Sham-Pre
Sham 10 mmHg x 5 minutes before procedure

Procedure: RIPost
Postconditioning 200 mmHg x 5 minutes after procedure

Sham Comparator: Sham + Sham
Intervention: Sham 10 mmHg + Sham 10 mmHg
Procedure: Sham-Pre
Sham 10 mmHg x 5 minutes before procedure

Procedure: Sham-Post
Sham 10 mmHg x 5 minutes after procedure




Primary Outcome Measures :
  1. Change in cardiac Troponin-T from baseline [ Time Frame: within 24 hours ]

Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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).

  5. 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. 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.


  7. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649309


Contacts
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Contact: Nakarin Sansanayudh, MD,PhD +6627639300 ext 93807 dr_nakarin@hotmail.com
Contact: Kitcha Champasri, MD +66897146999 dr.kitcha@hotmail.com

Locations
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Thailand
Department of Internal Medicine Recruiting
Bangkok, Thailand, 10400
Contact: Nakarin Sansanayudh, MD,PhD    +6623547600 ext 93827    dr_nakarin@hotmail.com   
Contact: Kitcha Champasri, MD    +66897146969    dr.kitcha@hotmail.com   
Sponsors and Collaborators
Phramongkutklao College of Medicine and Hospital
Investigators
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Principal Investigator: Nakarin Sansanayudh, MD,PhD Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand

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Responsible Party: Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier: NCT02649309     History of Changes
Other Study ID Numbers: PMK-SCRIP
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Phramongkutklao College of Medicine and Hospital:
Ischemic Preconditioning
Postconditioning
Angioplasty

Additional relevant MeSH terms:
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Reperfusion Injury
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications