Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction
- Conditions
- Post Myocardial Infarction
- Interventions
- Procedure: Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper armProcedure: Sham conditioning
- Registration Number
- NCT01664611
- Lead Sponsor
- University of Leicester
- Brief Summary
Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the peri/immediate post infarct period. However little is known as to the effect of repeated remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial, the investigators intend to carry out daily remote ischaemic conditioning in post MI patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks following a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic resonance imaging.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- LVEF < 45% on baseline ECHO
- First STEMI
- Successful revascularisation by PPCI
- Able to attend regional centre for follow-up appointment
- Competent to consent
- < 18 of age
- ICD or CRTP/D in-situ
- Prior history of heart failure
- Haemoglobin < 11.5 g/dl
- Creatinine > 200 µmol/L (eGFR<30ml/min/m2)
- Known malignancy/other comorbid condition which in the opinion of the investigator is likely to have significant negative influence on life expectancy
- Significant complications/illness following MI
- Unable to undergo cMRI
- Further planned coronary interventions
- Enrollment in another clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment arm Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm Participants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI Sham arm Sham conditioning Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI
- Primary Outcome Measures
Name Time Method Mean change in LVEF from baseline to 4 months as assessed by cMRI Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Primary outcome measure assessed at baseline and 4 months post MI. Mean change in LVEF from baseline to 4 months as assessed by cMRI
- Secondary Outcome Measures
Name Time Method Mean blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at baseline and 4 months post MI. Mean blood biomarker levels of heart failure and ventricular remodelling (e.g. NT-proBNP, MMP9, TIMP1) at baseline and 4 months
Final infarct size at 4 months as assessed by cMRI Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI. Final infarct size at 4 months as assessed by cMRI
Mean KCCQ score at 4 months Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI. Mean Kansas City Cardiomyopathy Screen (KCCQ) score at 4 months
Trial Locations
- Locations (1)
Univesrity of Leicester, Department of Cardiovascular Science
🇬🇧Leicester, Leicestershire, United Kingdom