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OpenTrials
Completed

NCT Number: NCT01664611

Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction

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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Key information

Conditions

Post Myocardial Infarction Cardiovascular Diseases Heart Diseases Heart Failure Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univesrity of Leicester, Department of Cardiovascular Science

Leicester, Leicestershire, LE3 9QP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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

Sham conditioning

Procedure

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

Primary outcomes

  1. 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.

    Mean change in LVEF from baseline to 4 months as assessed by cMRI

Secondary outcomes

  1. 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.

    Final infarct size at 4 months as assessed by cMRI

  2. Mean blood biomarker levels of heart failure and ventricular remodelling 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 blood biomarker levels of heart failure and ventricular remodelling (e.g. NT-proBNP, MMP9, TIMP1) at baseline and 4 months

  3. Mean 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.

    Mean Kansas City Cardiomyopathy Screen (KCCQ) score at 4 months

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • Freemasons' Medical Research Funding
  • University Hospitals, Leicester

Registry information

Official study title

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

Acronym: DREAM

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2012
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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