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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
90
Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion.
Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury
Univesrity of Leicester, Department of Cardiovascular Science
Leicester, Leicestershire, United Kingdom
Mean change in LVEF from baseline to 4 months as assessed by cMRI
Mean change in LVEF from baseline to 4 months as assessed by cMRI
Time frame: 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.
Final infarct size at 4 months as assessed by cMRI
Final infarct size at 4 months as assessed by cMRI
Time frame: 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 blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months
Mean blood biomarker levels of heart failure and ventricular remodelling (e.g. NT-proBNP, MMP9, TIMP1) at baseline and 4 months
Time frame: 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 KCCQ score at 4 months
Mean Kansas City Cardiomyopathy Screen (KCCQ) score at 4 months
Time frame: 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.
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