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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Trinity Health Ann Arbor
Ypsilanti, Michigan 48197
Contact:
Frank Smith, MD
734-712-8000
fsmith@michiganheart.com

Mission Health
Asheville, North Carolina 28803
Contact:
Brian Asbill, MD
828-274-6000
asbillbh@gmail.com

More Details

Status
Recruiting
Sponsor
Pritikin ICR

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.