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
About this trial
This is an interventional treatment trial for Post Procedural Myocardial Infarction
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
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
NCT ID
NCT03726164
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
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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