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Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction (DREAM)

Primary Purpose

Post Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm
Sham conditioning
Sponsored by
University of Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Myocardial Infarction focused on measuring Remote Ischaemic Conditioning, Remodeling, Heart Failure, Myocardial Infarction, Ischaemia/Reperfusion Injury, successful primary percutaneous coronary intervention following a first STEMI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univesrity of Leicester, Department of Cardiovascular Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment arm

Sham arm

Arm Description

Participants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI

Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Final infarct size at 4 months as assessed by cMRI
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
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
Mean Kansas City Cardiomyopathy Screen (KCCQ) score at 4 months

Full Information

First Posted
July 19, 2012
Last Updated
January 30, 2020
Sponsor
University of Leicester
Collaborators
University Hospitals, Leicester, Freemasons' Medical Research Funding
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1. Study Identification

Unique Protocol Identification Number
NCT01664611
Brief Title
Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction
Acronym
DREAM
Official Title
The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 26, 2012 (Actual)
Primary Completion Date
October 30, 2016 (Actual)
Study Completion Date
October 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leicester
Collaborators
University Hospitals, Leicester, Freemasons' Medical Research Funding

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Myocardial Infarction
Keywords
Remote Ischaemic Conditioning, Remodeling, Heart Failure, Myocardial Infarction, Ischaemia/Reperfusion Injury, successful primary percutaneous coronary intervention following a first STEMI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Participants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI
Arm Title
Sham arm
Arm Type
Sham Comparator
Arm Description
Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI
Intervention Type
Procedure
Intervention Name(s)
Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm
Other Intervention Name(s)
The electronic blood pressure cuff used to induce conditioning is the Accoson Greenlight 300., Cell Aegis AutoRIC machine
Intervention Description
Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion.
Intervention Type
Procedure
Intervention Name(s)
Sham conditioning
Intervention Description
Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury
Primary Outcome Measure Information:
Title
Mean change in LVEF from baseline to 4 months as assessed by cMRI
Description
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.
Secondary Outcome Measure Information:
Title
Final infarct size at 4 months as assessed by cMRI
Description
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.
Title
Mean blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months
Description
Mean blood biomarker levels of heart failure and ventricular remodelling (e.g. NT-proBNP, MMP9, TIMP1) 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.
Title
Mean KCCQ score at 4 months
Description
Mean Kansas City Cardiomyopathy Screen (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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilesh Samani, FRCP, MD, MBChB, BSc
Organizational Affiliation
University of Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univesrity of Leicester, Department of Cardiovascular Science
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE3 9QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35460434
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.
Results Reference
derived
PubMed Identifier
29748420
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.
Results Reference
derived

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Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction

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