ERIC-PPCI
Research type
Research Study
Full 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 study
IRAS ID
163086
Contact name
Derek Hausenloy
Contact email
Sponsor organisation
Joint Research Office
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 29 days
Research summary
During a heart attack (also known as a myocardial infarction or MI), damage to the heart muscle prevents it from pumping blood around the body effectively, which may result in the onset of heart failure.
The aim of the ERIC-PPCI study will be to investigate whether remote ischaemic conditioning (RIC), a simple and easy to administer treatment involving the inflation and deflation of a blood pressure cuff on the arm, can increase survival and prevent the onset of heart failure in patients undergoing a specific type of heart attack known as an ST elevation MI or STEMI. We hope it will do this by reducing the amount of damage to the heart muscle during the heart attack thereby preserving the pump action of the heart.The trial aims to recruit 2000 STEMI patients who are admitted to hospital and will receive a primary angioplasty which is a procedure to open up a completely blocked or partially blocked coronary or heart artery (this is known as a primary percutaneous intervention or PPCI). The trial will involve 30 hospitals in the UK. Patients will either receive RIC or a simulated RIC. The decision about whether the patient receives RIC or simulated RIC is made at random using a computer program.
In some of the hospitals patients will be given two extra heart MRI scans to assess in detail the function of the heart. The first scan will be done before the patient goes home. The patient will then be asked to return to the hospital again for the second scan 6 months after their heart attack. Travel expenses will be covered for any extra hospital visits which are not part of standard care. 250 patients will have these extra tests.
In some of the hospitals patients will have blood samples taken just before the angioplasty procedure and again at 6, 12, 24 and 48 hours. The blood samples will be used to measure the extent of the damage to the heart muscle. 400 patients will have these extra tests.
All patients will be seen routinely at 6-8 weeks after their heart attack. In case the patient is not going to return to the hospital this follow-up can also be done over the telephone.
All patients will be called at 1 year after their heart attack to collect some information on any further hospitals admissions or heart related illnesses. They will also be asked to complete a short quality of life questionnaire.
The results will be compared at 12 months to see which group has done better (RIC or simulated RIC).
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/0217
Date of REC Opinion
25 Mar 2015
REC opinion
Further Information Favourable Opinion