Multi-Center Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs
- Conditions
- Cardiovascular Diseases
- Interventions
- Behavioral: Intensive Cardiac RehabilitationBehavioral: Traditional Cardiac RehabilitationOther: C2life® Food
- Registration Number
- NCT06424119
- Lead Sponsor
- Pritikin ICR
- Brief Summary
The goal of this prospective study is to evaluate whether the Intensive Cardiac Rehabilitation (ICR) program provides incremental benefits over the Traditional Cardiac Rehabilitation (TCR) program, defined by readmission costs. The study aims to confirm:
* That ICR is associated with better outcomes than TCR, defined as lower readmission costs, lower incidence of major adverse cardiovascular events (MACE), and improvement in biomarkers, epigenetic markers, and inflammatory markers.
* The addition of food to the ICR program will further improve these outcomes.
ICR-eligible participants
* Will be randomized into one of three groups: (1) ICR 72 session program with home-delivered C2life® supplied food, (2) ICR 72 session without C2life® supplied food, or (3) TCR 36 session program without C2life supplied food
* Biometric measurements and laboratory measurements will be performed at entry into the rehab intervention, discharge from rehab intervention, and at 6 months after discharge.
* Epigenetic measurements will be performed at admission and discharge from the rehab intervention
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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.
- Anticipated life expectancy of under 2 years
- Any co-morbidity that would limit participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICR-Food Intensive Cardiac Rehabilitation Intensive Cardiac Rehab (ICR_ 72-session program with C2life® supplied food ICR-No Food Intensive Cardiac Rehabilitation Intensive Cardiac Rehab (ICR) 72-session program without C2life® supplied food ICR-Food C2life® Food Intensive Cardiac Rehab (ICR_ 72-session program with C2life® supplied food TCR-No Food Traditional Cardiac Rehabilitation Traditional Cardiac Rehab (TCR) 36-session program without C2life® supplied food
- Primary Outcome Measures
Name Time Method Readmission Rate Data Followup may extend up to 5 years for a post-hoc EMR analysis. Readmission rate data will include:
1. Actual number of all cause readmissions
2. Days in hospital for each readmission
3. Cost of readmission.
Stratification between all cause and cardiovascular readmissions will be performed as an additional sub-analysis.
- Secondary Outcome Measures
Name Time Method Composite Total Readmission Rates At 1 and 2 years Number of readmissions within 2 years.
MACE At 1 and 2 years. MACE is defined as all-cause death, non-fatal MI, hospitalization for unstable angina, PCI, CABG, peripheral artery revascularization, Ischemic stroke, CHF hospitalization, heart valve surgery, and heart transplant.
Readmission Days At 1 and 2 years Composite length of stay in days for the total readmission events and each MACE category within 2 years.
Dietary Inflammation Index (DII) At admission, discharge from program (about 12 weeks), and 6 month post-discharge Scores will be calculated for the C2life® diet as a whole and for each participant at the prespecified measurement times.
Labs At admission, discharge (about 12 weeks), and 6 months post-discharge Labs will include lipids, comprehensive metabolic profile, HbA1c, Hs-CRP, IL-6, TNF-alpha, IFN-gamma, and ceramides.
Epigenetic Biomarkers Performed by Prosper eDNA® Buccal swab at admission and discharge (about 12 weeks) Buccal swab samples will be taken to obtain this data. We propose to use a set of epigenetic biomarkers to measure biological age, metabolic health, inflammation, and overall fitness.
Trial Locations
- Locations (3)
Trinity Health Ann Arbor
🇺🇸Ypsilanti, Michigan, United States
Mission Health
🇺🇸Asheville, North Carolina, United States
Ballad CVA Heart Institute
🇺🇸Kingsport, Tennessee, United States