Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction (DREAM)

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

Tracking Information

• First Submitted Date: July 19, 2012
• First Posted Date: August 14, 2012
• Last Update Posted Date: January 31, 2020
• Actual Study Start Date: September 26, 2012
• Actual Primary Completion Date: October 30, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Other
• Condition: Post Myocardial Infarction

Intervention

• 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

• 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 *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 9, 2012): 90
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 30, 2016
• Actual Primary Completion Date: October 30, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01664611
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: University of Leicester
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Leicester
• Original Study Sponsor: Same as current

Collaborators

• University Hospitals, Leicester
• Freemasons' Medical Research Funding

Investigators

• Principal Investigator: Nilesh Samani, FRCP, MD, MBChB, BSc; University of Leicester

• PRS Account: University of Leicester
• Verification Date: August 2012