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NCT Number: NCT06424119

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

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

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trinity Health Ann Arbor, Ypsilanti, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Cardiac Rehabilitation

Behavioral

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.

Other names: TCR

Intensive Cardiac Rehabilitation

Behavioral

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 names: ICR

C2life® Food

Other

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.

Primary outcomes

  1. Readmission Rate Data

    Time frame: Followup may extend up to 5 years for a post-hoc EMR analysis.

    Readmission rate data will include:

    • Actual number of all cause readmissions
    • Days in hospital for each readmission
    • Cost of readmission.

    Stratification between all cause and cardiovascular readmissions will be performed as an additional sub-analysis.

Secondary outcomes

  1. MACE

    Time frame: 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.

  2. Composite Total Readmission Rates

    Time frame: At 1 and 2 years

    Number of readmissions within 2 years.

  3. Readmission Days

    Time frame: At 1 and 2 years

    Composite length of stay in days for the total readmission events and each MACE category within 2 years.

  4. Dietary Inflammation Index (DII)

    Time frame: 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.

  5. Labs

    Time frame: 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.

  6. Epigenetic Biomarkers Performed by Prosper eDNA®

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pritikin ICR

Other

Collaborators

  • Ballad Health
  • Connecting Health Innovation
  • Mission Health System, Asheville, NC
  • Trinity Health System

Registry information

Official study title

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

Acronym: CREDIBLE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 21, 2024
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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