RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-04-26
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06424119

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * Anticipated life expectancy of under 2 years
  2. * Any co-morbidity that would limit participation in the study.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Pritikin ICR

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

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 Registration Dates

Study Start Date2024-04-26
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-04-26
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Intensive Cardiac Rehabilitation
  • Traditional Cardiac Rehabilitation

Additional Relevant MeSH Terms

  • Cardiovascular Diseases