Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction
DREAM
The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
August 14, 2012
CompletedStudy Start
First participant enrolled
September 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2016
CompletedJanuary 31, 2020
August 1, 2012
4.1 years
July 19, 2012
January 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in LVEF from baseline to 4 months as assessed by cMRI
Mean change in LVEF from baseline to 4 months as assessed by cMRI
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.
Secondary Outcomes (3)
Final infarct size at 4 months as assessed by cMRI
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 blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months
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 KCCQ score at 4 months
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.
Study Arms (2)
Treatment arm
EXPERIMENTALParticipants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI
Sham arm
SHAM COMPARATORParticipants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI
Interventions
Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion.
Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury
Eligibility Criteria
You may qualify if:
- LVEF \< 45% on baseline ECHO
- First STEMI
- Successful revascularisation by PPCI
- Able to attend regional centre for follow-up appointment
- Competent to consent
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leicesterlead
- University Hospitals, Leicestercollaborator
- Freemasons' Medical Research Fundingcollaborator
Study Sites (1)
Univesrity of Leicester, Department of Cardiovascular Science
Leicester, Leicestershire, LE3 9QP, United Kingdom
Related Publications (2)
Arnold JR, P Vanezis A, Rodrigo GC, Lai FY, Kanagala P, Nazir S, Khan JN, Ng L, Chitkara K, Coghlan JG, Hetherington S, Samani NJ, McCann GP. Effects of late, repetitive remote ischaemic conditioning on myocardial strain in patients with acute myocardial infarction. Basic Res Cardiol. 2022 Apr 23;117(1):23. doi: 10.1007/s00395-022-00926-7.
PMID: 35460434DERIVEDVanezis 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.
PMID: 29748420DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nilesh Samani, FRCP, MD, MBChB, BSc
University of Leicester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2012
First Posted
August 14, 2012
Study Start
September 26, 2012
Primary Completion
October 30, 2016
Study Completion
October 30, 2016
Last Updated
January 31, 2020
Record last verified: 2012-08
Data Sharing
- IPD Sharing
- Will not share