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

May 15, 2024 updated by: Pritikin ICR

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health Ann Arbor
        • Contact:
        • Contact:
          • Autumn Howe, RN
          • Phone Number: (734)712-8387
        • Principal Investigator:
          • Frank A. Smith, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Mission Health
        • Contact:
        • Principal Investigator:
          • Brian Asbill, MD
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Not yet recruiting
        • Ballad CVA Heart Institute
        • Contact:
        • Principal Investigator:
          • David Beckner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICR-No Food
Intensive Cardiac Rehab (ICR) 72-session program without C2life® supplied food
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 Names:
  • ICR
Experimental: ICR-Food
Intensive Cardiac Rehab (ICR_ 72-session program with C2life® supplied food
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 Names:
  • ICR
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.
Active Comparator: TCR-No Food
Traditional Cardiac Rehab (TCR) 36-session program without C2life® supplied food
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.
Other Names:
  • TCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission Rate Data
Time Frame: 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.
Followup may extend up to 5 years for a post-hoc EMR analysis.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 1 and 2 years.
Composite Total Readmission Rates
Time Frame: At 1 and 2 years
Number of readmissions within 2 years.
At 1 and 2 years
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.
At 1 and 2 years
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.
At admission, discharge from program (about 12 weeks), and 6 month post-discharge
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.
At admission, discharge (about 12 weeks), and 6 months post-discharge
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.
Buccal swab at admission and discharge (about 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pritikin ICR

Collaborators

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

Investigators

  • Principal Investigator: Brian Asbill, MD, Mission Health
  • Principal Investigator: David Beckner, MD, Ballad Health
  • Principal Investigator: Frank A. Smith, MD, Trinity Health
  • Principal Investigator: James R. Hebert, ScD, MSPH, Connecting Health Innovations, LLC (CHI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 12, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREDIBLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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