Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)

Conditions
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Post Myocardial Infarction

Intervention / Treatment
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* Procedure: Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm
* Procedure: Sham conditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Participants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI | Procedure: Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm<br>* Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion.<br>* Other names: Cell Aegis AutoRIC machine;|
| Sham Comparator: Sham arm<br>Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI | Procedure: Sham conditioning<br>* Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final infarct size at 4 months as assessed by cMRI | 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. | 
| 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote Ischaemic Conditioning, Remodeling, Heart Failure, Myocardial Infarction, Ischaemia/Reperfusion Injury, successful primary percutaneous coronary intervention following a first STEMI