Cardiovascular Diseases
Conditions
Keywords
Intensive Cardiac Rehabilitation, Traditional Cardiac Rehabilitation
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
Interventions
BEHAVIORALTraditional 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.
BEHAVIORALIntensive 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.
OTHERC2life® 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.
Sponsors
Ballad Health
Mission Health System, Asheville, NC
Trinity Health System
Connecting Health Innovation
Pritikin ICR
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
ICR-eligible patients are randomized into one of three groups of 150 patients: (1) ICR 72 session program with C2life® supplied food, (2) ICR 72 session without C2life® supplied food, or (3) TCR 36 session program without C2life supplied food (ICR-food, ICR-no food, and TCR-no food).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Composite Total Readmission Rates | At 1 and 2 years | Number of readmissions within 2 years. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed