Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction

Post Myocardial Infarction Clinical Trial

— DREAM  

Official title:

The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01664611
• Other study ID #: 0306
• Status: Completed
• Phase: N/A
• Start date: September 26, 2012
• Est. completion date: October 30, 2016

Study information

• Verified date: August 2012
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 30, 2016
• Est. primary completion date: October 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• 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.
• Sham conditioning
Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury

Locations

Country	Name	City	State
United Kingdom	Univesrity of Leicester, Department of Cardiovascular Science	Leicester	Leicestershire

Sponsors (3)

Lead Sponsor	Collaborator
University of Leicester	Freemasons' Medical Research Funding, University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Final infarct size at 4 months as assessed by cMRI	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.
Secondary	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	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.
Secondary	Mean KCCQ score at 4 months	Mean Kansas City Cardiomyopathy Screen (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.