Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (ERIC-PPCI)
|ClinicalTrials.gov Identifier: NCT02342522|
Recruitment Status : Active, not recruiting
First Posted : January 21, 2015
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|STEMI Myocardial Reperfusion Injury||Device: Remote ischemic conditioning Device: Sham control||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Remote Ischaemic Conditioning on Clinical Outcomes in ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention (ERIC-PPCI): A Multicentre Randomised Controlled Clinical Trial|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Remote ischemic conditioning
On arrival at the hospital an AutoRIC device will be placed on the upper arm and an active RIC protocol will be delivered (4x5 min cycles of inflation to 220mmHg and deflation).
Device: Remote ischemic conditioning
An automated autoRIC™ cuff will be placed on the upper arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle which will be undertaken 4 times in total. For patients presenting with a systolic blood pressure (SBP)≥175mmHg, a manual blood pressure cuff will be used and inflated to 25 mmHg above systolic blood pressure.
Sham Comparator: Sham control
On arrival at the hospital an AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered (4x5 min cycles of simulated inflation and deflation).
Device: Sham control
An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.
- Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year. [ Time Frame: One year ]
- Rates of cardiac death and HHF at 30 days. [ Time Frame: 30 days ]
- Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months. [ Time Frame: 12 months ]
- TIMI flow post-PPCI. [ Time Frame: 30 days ]
- Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L). [ Time Frame: One year ]
- Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) hsTrop T and CK-MB. [ Time Frame: 1 week ]
- CMR substudy: Cardiac MRI in first week and at 6 months (primary endpoint infarct size at 6 mths). [ Time Frame: 6 months ]
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): NCT02342522
|St Thomas Hospital|
|London, United Kingdom|
|John Radcliffe Hospital|
|Oxford, United Kingdom|
|Principal Investigator:||Derek Hausenloy, MD PhD||The Hatter Cardiovascular Institute, University College London|