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Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction (DREAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 19, 2012
First Posted Date  ICMJE August 14, 2012
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE September 26, 2012
Actual Primary Completion Date October 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2012)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction
Official Title  ICMJE The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Post Myocardial Infarction
Intervention  ICMJE
  • 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
  • Procedure: Sham conditioning
    Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury
Study Arms  ICMJE
  • Experimental: Treatment arm
    Participants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI
    Intervention: Procedure: Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm
  • Sham Comparator: Sham arm
    Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI
    Intervention: Procedure: Sham conditioning
Publications * Vanezis AP, Arnold JR, Rodrigo G, Lai FY, Debiec R, Nazir S, Khan JN, Ng LL, Chitkara K, Coghlan JG, Hetherington SL, McCann GP, Samani NJ. Daily remote ischaemic conditioning following acute myocardial infarction: a randomised controlled trial. Heart. 2018 Dec;104(23):1955-1962. doi: 10.1136/heartjnl-2018-313091. Epub 2018 May 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 30, 2016
Actual Primary Completion Date October 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01664611
Other Study ID Numbers  ICMJE 0306
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Leicester
Study Sponsor  ICMJE University of Leicester
Collaborators  ICMJE
  • University Hospitals, Leicester
  • Freemasons' Medical Research Funding
Investigators  ICMJE
Principal Investigator: Nilesh Samani, FRCP, MD, MBChB, BSc University of Leicester
PRS Account University of Leicester
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP