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RECRUITING
NCT06424119
NA

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

Sponsor: Pritikin ICR

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2024-04-26

Completion Date

2027-12-31

Last Updated

2024-05-21

Healthy Volunteers

No

Interventions

BEHAVIORAL

Traditional Cardiac Rehabilitation

Patient must have a qualifying cardiovascular event and eligible for ICR. Once patient is randomized to TCR arm, they will attend 36 sessions of the program at one of three locations.

BEHAVIORAL

Intensive Cardiac Rehabilitation

Patient must have a qualifying cardiovascular event and eligible for ICR. Once patient is randomized to ICR arm, they will attend 72 sessions of the program at one of three locations.

OTHER

C2life® Food

Patient must have a qualifying cardiovascular event and eligible for ICR. Once patient is randomized to ICR arm with food, they will receive the food at the beginning of the second week of their respective program. Food will be delivered by mail weekly for a total of 11 weeks to the patient's home address.

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