Clinical trial NCT06424119: Multi-Center Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs
Official title: Multi-Center Randomized Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs (CREDIBLE Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Intensive Cardiac Rehabilitation
Traditional Cardiac Rehabilitation
Lead sponsor: Pritikin ICR
Sponsor class: OTHER
Collaborators: name: Ballad Health
name: Mission Health System, Asheville, NC
name: Trinity Health System
name: Connecting Health Innovation
First posted: 2024-05-21
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Readmission Rate Data
timeFrame: Followup may extend up to 5 years for a post-hoc EMR analysis.
Secondary outcomes:
measure: MACE
timeFrame: At 1 and 2 years.
measure: Composite Total Readmission Rates
timeFrame: At 1 and 2 years
measure: Readmission Days
timeFrame: At 1 and 2 years
measure: Dietary Inflammation Index (DII)
timeFrame: At admission, discharge from program (about 12 weeks), and 6 month post-discharge
measure: Labs
timeFrame: At admission, discharge (about 12 weeks), and 6 months post-discharge
measure: Epigenetic Biomarkers Performed by Prosper eDNA®
timeFrame: Buccal swab at admission and discharge (about 12 weeks)
Other outcomes:
Locations:
city: Ypsilanti
country: United States
facility: Trinity Health Ann Arbor
state: Michigan
city: Asheville
country: United States
facility: Mission Health
state: North Carolina
city: Kingsport
country: United States
facility: Ballad CVA Heart Institute
state: Tennessee
Study officials:
affiliation: Mission Health
name: Brian Asbill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ballad Health
name: David Beckner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Trinity Health System
name: Frank A. Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Connecting Health Innovations, LLC (CHI)
name: James R. Hebert, ScD, MSPH
role: PRINCIPAL_INVESTIGATOR
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