Comparing Intensive and Traditional Cardiac Rehabilitation Programs
Multi-Center Randomized Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs (CREDIBLE Study)
This study is testing if an Intensive Cardiac Rehabilitation program, with or without home-delivered food, works better than a Traditional Cardiac Rehabilitation program for people recovering from heart issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pritikin ICR Academic / other |
| Locations | 3 sites (Ypsilanti, Michigan and 2 other locations) |
| Trial ID | NCT06424119 on ClinicalTrials.gov |
What this trial studies
This prospective study evaluates the benefits of an Intensive Cardiac Rehabilitation (ICR) program compared to a Traditional Cardiac Rehabilitation (TCR) program, focusing on readmission costs and cardiovascular outcomes. Participants will be randomized into three groups: one receiving ICR with home-delivered food, one receiving ICR without food, and one receiving TCR. The study will measure various health outcomes, including major adverse cardiovascular events and improvements in biomarkers, at multiple time points. The goal is to determine if ICR provides superior benefits over TCR.
Who should consider this trial
Good fit: Ideal candidates include patients eligible for Intensive Cardiac Rehabilitation following specific cardiovascular events such as myocardial infarction or coronary artery bypass.
Not a fit: Patients with a life expectancy of under 2 years or significant co-morbidities that limit participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes and reduced healthcare costs for patients undergoing cardiac rehabilitation.
How similar studies have performed: Other studies have shown promising results with intensive rehabilitation approaches, suggesting potential for success in this study as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients eligible for an Intensive Cardiac Rehabilitation (ICR) Program at each of the three study sites outline below, stratified by one of the following qualifying cardiovascular events, including myocardial infarction (STEMI and NSTEMI), angioplasty and stents, coronary artery bypass, surgical or percutaneous valve repair or replacement, and stable congestive heart failure with reduced ejection fraction of 35% or less. Exclusion Criteria: * Anticipated life expectancy of under 2 years * Any co-morbidity that would limit participation in the study.
Where this trial is running
Ypsilanti, Michigan and 2 other locations
- Trinity Health Ann Arbor — Ypsilanti, Michigan, United States (Recruiting)
- Mission Health — Asheville, North Carolina, United States (Recruiting)
- Ballad CVA Heart Institute — Kingsport, Tennessee, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Brian Asbill, MD — Mission Health
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.