Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)
- Conditions
- STEMIMyocardial Reperfusion Injury
- Interventions
- Device: ControlDevice: Remote ischemic conditioning
- Registration Number
- NCT02342522
- Lead Sponsor
- University College, London
- Brief Summary
The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure at 12 months in patients presenting with a ST-elevation myocardial infarction and treated by percutaneous coronary intervention.
- Detailed Description
The CONDI2/ERIC-PPCI trial is a randomised controlled clinical trial investigating whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in 5400 patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5413
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham control Control Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI. Remote ischemic conditioning 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.
- Primary Outcome Measures
Name Time Method Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year. One year
- Secondary Outcome Measures
Name Time Method Rates of cardiac death and HHF at 30 days. 30 days Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months. 12 months TIMI flow post-PPCI. 1 week Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L). One year Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers 1 week CMR substudy: Cardiac MRI in first week and at 6 months 6 months
Trial Locations
- Locations (35)
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Clinical Centre of Serbia
🇷🇸Belgrade, Serbia
Aalborg University Hospital
🇩🇰Aalborg, Denmark
William Harvey Hospital
🇬🇧Ashford, United Kingdom
Basildon University Hospital
🇬🇧Basildon, United Kingdom
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Papworth Hospital
🇬🇧Cambridge, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Coventry University Hospital
🇬🇧Coventry, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, United Kingdom
Kettering General Hospital
🇬🇧Kettering, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
Kings College London Hospital
🇬🇧London, United Kingdom
St Thomas Hospital
🇬🇧London, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Lister Hospital
🇬🇧Stevenage, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Prehospital Emergency Medical Service, North Denmark Region
🇩🇰Aalborg, Denmark
Prehospital Emergency Medical Service, Central Denmark Region
🇩🇰Aarhus, Denmark
Prehospital Emergency Medical Service, Region Zealand
🇩🇰Ballerup, Denmark
Rigshospitalet
🇩🇰København, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Prehospital Emergency Medical Service , South Denmark Region
🇩🇰Vejle, Denmark
Royal Sussex County Hospital
🇬🇧Brighton, Sussex, United Kingdom
The Royal Free Hospital
🇬🇧London, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, United Kingdom