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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
450
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.
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.
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.
Trinity Health Ann Arbor
Ypsilanti, Michigan, United States
RECRUITINGMission Health
Asheville, North Carolina, United States
RECRUITINGBallad CVA Heart Institute
Kingsport, Tennessee, United States
NOT_YET_RECRUITINGReadmission Rate Data
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.
Time frame: Followup may extend up to 5 years for a post-hoc EMR analysis.
MACE
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.
Time frame: At 1 and 2 years.
Composite Total Readmission Rates
Number of readmissions within 2 years.
Time frame: At 1 and 2 years
Readmission Days
Composite length of stay in days for the total readmission events and each MACE category within 2 years.
Time frame: At 1 and 2 years
Dietary Inflammation Index (DII)
Scores will be calculated for the C2life® diet as a whole and for each participant at the prespecified measurement times.
Time frame: At admission, discharge from program (about 12 weeks), and 6 month post-discharge
Labs
Labs will include lipids, comprehensive metabolic profile, HbA1c, Hs-CRP, IL-6, TNF-alpha, IFN-gamma, and ceramides.
Time frame: At admission, discharge (about 12 weeks), and 6 months post-discharge
Epigenetic Biomarkers Performed by Prosper eDNA®
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.
Time frame: Buccal swab at admission and discharge (about 12 weeks)
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