Impact of Cardiac Rehabilitation Programs on Left Ventricular Remodeling After Acute Myocardial Infarction - the REHAB Trial
1 other identifier
observational
100
1 country
1
Brief Summary
The aim of REHAB trial is to investigate the impact of early mobilization after AMI in reducing left ventricular remodeling, as assessed by cardiac magnetic resonance imaging. At the same time, the study aims to demonstrate the contribution of early mobilization to reduction of: systemic inflammation in the immediate post infarction phase, complication rates and mortality, in patients who had suffered a recent AMI, for a 1 year follow-up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedStudy Start
First participant enrolled
January 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedAugust 2, 2022
November 1, 2019
11 months
October 28, 2019
July 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Ventricular remodeling in the post-infarction period
LGE-CMR evaluation for myocardial fibrosis/scar, infarct size, transmurality, remodeling assessment.
Month 1
Secondary Outcomes (2)
Major adverse cardiovascular events
12 months
Systemic inflammation in the immediate postinfarction phase
Day 7
Study Arms (2)
RHB-SG 01
Patients with early mobilization (\< 2 days after the onset of symptoms)
RHB-SG 02
Patients with delayed mobilization after AMI (\>2 days after the onset of symptoms)
Interventions
* Transthoracic echocardiography * Late gadolinium enhancement CMR
* complete blood count * biochemistry * hs-CRP, MMPs, IL6, NT-pro-BNP
Eligibility Criteria
100 patients with AMI, presenting with either ST-segment elevation acute myocardial infarction (STEMI) or non-ST-segment elevation AMI (NSTEMI).
You may qualify if:
- Patients with AMI in the last 12 hours;
- Successful revascularization of the culprit artery within the first 12 hours after the onset of symptoms in STEMI or within first 48 hours in NSTEMI (according to the risk class);
- Signed written informed consent.
You may not qualify if:
- Patient refusal;
- Any condition that would contraindicate CMR examination;
- Women during pregnancy or lactation period;
- Women able to procreate without any contraceptive usage;
- Chronic kidney disease (glomerular filtration rate \<60ml/min/1.73m2) or acute renal injury that requires hemodialysis;
- Any type of neoplasia documented in the last 3 years before randomization;
- Expectation of life \< 1 year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardio Med Medical Center
Târgu Mureş, 540124, Romania
Biospecimen
Collection of venous blood samples at baseline and at 7 days after AMI for assessment of complete blood count, biochemistry, serum levels of hs-CRP, MMPs, IL6, NT-pro-BNP.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
November 13, 2019
Study Start
January 10, 2020
Primary Completion
November 30, 2020
Study Completion
November 30, 2021
Last Updated
August 2, 2022
Record last verified: 2019-11