Multi-Center Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs (CREDIBLE)

Pritikin ICR

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Intensive Cardiac Rehabilitation; Other: C2life® Food; Behavioral: Traditional Cardiac Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06424119

CREDIBLE

Details and patient eligibility

About

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

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 3 patient groups

ICR-No Food

Experimental group

Description:

Intensive Cardiac Rehab (ICR) 72-session program without C2life® supplied food

Treatment:

Behavioral: Intensive Cardiac Rehabilitation

ICR-Food

Experimental group

Description:

Intensive Cardiac Rehab (ICR_ 72-session program with C2life® supplied food

Treatment:

Other: C2life® Food

Behavioral: Intensive Cardiac Rehabilitation

TCR-No Food

Active Comparator group

Description:

Traditional Cardiac Rehab (TCR) 36-session program without C2life® supplied food

Treatment:

Behavioral: Traditional Cardiac Rehabilitation