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Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI

Primary Purpose

Post Procedural Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote Conditioning
Sham protocol
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Procedural Myocardial Infarction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention

Exclusion Criteria:

  • Known renal failure
  • Known liver disease
  • Peripheral vascular disease involving upper limbs
  • Inability to consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Remote Conditioning group

    Control Group

    Arm Description

    Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.

    Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.

    Outcomes

    Primary Outcome Measures

    Peri-Procedural Myocardial Injury
    Peri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T>3x 99th percentile upper reference limit

    Secondary Outcome Measures

    Full Information

    First Posted
    May 8, 2017
    Last Updated
    November 4, 2020
    Sponsor
    University College, London
    Collaborators
    University College London Hospitals, Surrey and Sussex Healthcare NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03726164
    Brief Title
    Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI
    Official Title
    A Study Investigating the Cardioprotective Benefits of Remote Ischaemic Postconditioning in Patients Presenting With Non ST Elevation Acute Coronary Syndromes Undergoing In-hospital Percutaneous Coronary Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University College, London
    Collaborators
    University College London Hospitals, Surrey and Sussex Healthcare NHS Trust

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI.
    Detailed Description
    Patients presenting with Non ST elevation acute coronary syndromes (NSTEACS) - NSTEMI and Unstable angina patients are enrolled in this study. Eligible patients are approached, with patient information sheets and are consented for involvement into the study. Patients are randomised to intervention or control. Patients randomised to intervention will receive 3 x 5 minutes of forearm ischaemia (with the cuff inflated to 200 mmHg) separated by 5 minutes of reperfusion between each cuff inflation, prior coronary angiography. This protocol of episodic forearm ischaemia/reperfusion has been demonstrated to confer remote ischaemic preconditioning-induced protection. Prior to the intervention, a blood sample will be taken to measure serum troponin T and CK-MB (baseline level). Following PCI patients will be reviewed on the wards and their ongoing recovery will be assessed and reviewed prior to discharge from the study. Troponin T and CK-MB levels will be measured for the 24 hours after PCI, at various time points (6 hour, 12 hour, 24 hour) as a measure of the degree of myocardial damage, and levels compared between the different treatment groups. Primary end point Myocardial injury (Peri-procedural Myocardial Infarction and Injury) measured by cTnT and CK-MB release over 24 hours after primary PCI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Procedural Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    626 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Remote Conditioning group
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.
    Intervention Type
    Device
    Intervention Name(s)
    Remote Conditioning
    Other Intervention Name(s)
    RIC
    Intervention Description
    A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.
    Intervention Type
    Device
    Intervention Name(s)
    Sham protocol
    Other Intervention Name(s)
    Control
    Intervention Description
    An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
    Primary Outcome Measure Information:
    Title
    Peri-Procedural Myocardial Injury
    Description
    Peri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T>3x 99th percentile upper reference limit
    Time Frame
    24 hours post PCI

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention Exclusion Criteria: Known renal failure Known liver disease Peripheral vascular disease involving upper limbs Inability to consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Derek M Yellon, PhD, FACC
    Organizational Affiliation
    University College, London
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI

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