Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI
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|ClinicalTrials.gov Identifier: NCT03726164|
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post Procedural Myocardial Infarction||Device: Remote Conditioning Device: Sham protocol||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||624 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||June 2008|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Remote Conditioning group
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.
Device: Remote Conditioning
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.
Other Name: RIC
Placebo Comparator: Control Group
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.
Device: Sham protocol
An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
Other Name: Control
- Peri-Procedural Myocardial Injury [ Time Frame: 24 hours post PCI ]Peri-Procedural Myocardial Injury will be assessed by the 24 hours area under the curve serum Troponin release
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): NCT03726164
|Study Director:||Derek M Yellon, PhD, FACC||University College, London|