Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-26

Study Completion Date

2016-10-30

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.

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Detailed Description

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Conditions

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Post Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment arm

Participants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI

Group Type EXPERIMENTAL

Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm

Intervention Type PROCEDURE

Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion.

Sham arm

Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI

Group Type SHAM_COMPARATOR

Sham conditioning

Intervention Type PROCEDURE

Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury

Interventions

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Remote 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.

Intervention Type PROCEDURE

Sham conditioning

Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury

Intervention Type PROCEDURE

Other Intervention Names

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The electronic blood pressure cuff used to induce conditioning is the Accoson Greenlight 300. Cell Aegis AutoRIC machine

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No