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Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction (DREAM)

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ClinicalTrials.gov Identifier: NCT01664611
Recruitment Status : Completed
First Posted : August 14, 2012
Last Update Posted : January 31, 2020
Sponsor:
Collaborators:
University Hospitals, Leicester
Freemasons' Medical Research Funding
Information provided by (Responsible Party):
University of Leicester

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Post Myocardial Infarction Procedure: Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm Procedure: Sham conditioning Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)
Actual Study Start Date : September 26, 2012
Actual Primary Completion Date : October 30, 2016
Actual Study Completion Date : October 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
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 Names:
  • The electronic blood pressure cuff used to induce conditioning is the Accoson Greenlight 300.
  • Cell Aegis AutoRIC machine
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664611


Locations
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United Kingdom
Univesrity of Leicester, Department of Cardiovascular Science
Leicester, Leicestershire, United Kingdom, LE3 9QP
Sponsors and Collaborators
University of Leicester
University Hospitals, Leicester
Freemasons' Medical Research Funding
Investigators
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Principal Investigator: Nilesh Samani, FRCP, MD, MBChB, BSc University of Leicester
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT01664611    
Other Study ID Numbers: 0306
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: August 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases