Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction (DREAM)

University of Leicester

Status: Completed

Conditions: Post Myocardial Infarction

Treatments: Procedure: Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm; Procedure: Sham conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01664611

0306

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Treatment arm

Experimental group

Description:

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

Treatment:

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

Sham arm

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham conditioning