Post Myocardial Infarction
Conditions
Keywords
Remote Ischaemic Conditioning, Remodeling, Heart Failure, Myocardial Infarction, Ischaemia/Reperfusion Injury, successful primary percutaneous coronary intervention following a first STEMI
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.
Interventions
PROCEDURERemote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm
Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion.
PROCEDURESham conditioning
Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury
Sponsors
University Hospitals, Leicester
Freemasons' Medical Research Funding
University of Leicester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* LVEF \< 45% on baseline ECHO * First STEMI * Successful revascularisation by PPCI * Able to attend regional centre for follow-up appointment * Competent to consent
Exclusion criteria
* \< 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed