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Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction (DREAM)

This study is currently recruiting participants.
Verified August 2012 by University of Leicester
Sponsor:
Collaborators:
Leicester Cardiovascular Biomedical Research Unit
University Hospitals, Leicester
Freemasons' Medical Research Funding
Information provided by (Responsible Party):
University of Leicester
ClinicalTrials.gov Identifier:
NCT01664611
First received: July 19, 2012
Last updated: December 4, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Post Myocardial Infarction
 Procedure: Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm
Procedure: Sham conditioning
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leicester:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Mean change in LVEF from baseline to 4 months as assessed by cMRI


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Final infarct size at 4 months as assessed by cMRI

  • 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. ] [ Designated as safety issue: No ]
    Mean blood biomarker levels of heart failure and ventricular remodelling (e.g. NT-proBNP, MMP9, TIMP1) at baseline and 4 months

  • 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. ] [ Designated as safety issue: No ]
    Mean Kansas City Cardiomyopathy Screen (KCCQ) score at 4 months


Estimated Enrollment: 90
Study Start Date: September 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
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
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 Name: The elctronic blood pressure cuff used to induce conditioning is the Accoson Greenlight 300.
Sham Comparator: Sham arm
Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI
 Procedure: Sham conditioning
Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LVEF < 45% on baseline ECHO
  • First STEMI
  • Successful revascularisation by PPCI
  • Able to attend Glenfield Hospital for 4 month follow-up appointment
  • Competent to consent

Exclusion Criteria:

  • < 18 or > 80 years 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664611

Locations
United Kingdom
Univesrity of Leicester, Department of Cardiovascular Science Recruiting
Leicester, Leicestershire, United Kingdom, LE3 9QP
Contact: Louise Goddard     +44 116 258 3045     lg2@le.ac.uk    
Sponsors and Collaborators
University of Leicester
Leicester Cardiovascular Biomedical Research Unit
University Hospitals, Leicester
Freemasons' Medical Research Funding
Investigators
Principal Investigator: Nilesh Samani, FRCP, MD, MBChB, BSc University of Leicester
  More Information

No publications provided

Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT01664611     History of Changes
Other Study ID Numbers: UNOLE 0306
Study First Received: July 19, 2012
Last Updated: December 4, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Leicester:
Remote Ischaemic Conditioning
Remodeling
Heart Failure
 Myocardial Infarction
Ischaemia/Reperfusion Injury
successful primary percutaneous coronary intervention following a first STEMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013