Multi-Center Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs
Start Date
4/26/2024
Completion Date
12/31/2027
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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Traditional Cardiac Rehabilitation
Intensive Cardiac Rehabilitation
C2life® Food
Conditions
Locations
Trinity Health Ann Arbor
Ypsilanti, Michigan 48197
United States
Mission Health
Asheville, North Carolina 28803
United States
Ballad CVA Heart Institute
Kingsport, Tennessee 37660
United States