Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)
|ClinicalTrials.gov Identifier: NCT02342522|
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : August 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|STEMI Myocardial Reperfusion Injury||Device: Remote ischemic conditioning Device: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5413 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 (CONDI2/ERIC-PPCI)|
|Actual Study Start Date :||November 2013|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
Active Comparator: Remote ischemic conditioning
AutoRIC device will be placed on the upper arm and an active RIC protocol will be delivered (4x5 min cycles of inflation to 200mmHg and deflation) prior to PPCI.
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.
Sham Comparator: Sham control
Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI.
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: 1 week ]
- 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) cardiac biomarkers [ Time Frame: 1 week ]
- CMR substudy: Cardiac MRI in first week and at 6 months [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342522
|Principal Investigator:||Derek Hausenloy, MD PhD||The Hatter Cardiovascular Institute, University College London|
|Principal Investigator:||Hans Erik Botker, MD PhD||Department of Clinical Medicine, Aarhus University|