Clinical trial NCT01664611: Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction
Official title: The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Myocardial Infarction
Keywords: Remote Ischaemic Conditioning
Remodeling
Heart Failure
Myocardial Infarction
Ischaemia/Reperfusion Injury
successful primary percutaneous coronary intervention following a first STEMI
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
name: Freemasons' Medical Research Funding
First posted: 2012-08-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Mean change in LVEF from baseline to 4 months as assessed by cMRI
timeFrame: 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:
measure: Final infarct size at 4 months as assessed by cMRI
timeFrame: 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.
measure: Mean blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months
timeFrame: 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.
measure: Mean KCCQ score at 4 months
timeFrame: 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.
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Univesrity of Leicester, Department of Cardiovascular Science
state: Leicestershire
Study officials:
affiliation: University of Leicester
name: Nilesh Samani, FRCP, MD, MBChB, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.