Recruiting

Cardiac Rehabilitation

Sponsor:

Pritikin ICR

Code:

NCT06424119

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Traditional Cardiac Rehabilitation

Intensive Cardiac Rehabilitation

C2life® Food

Study Details

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

Conditions

Cardiovascular Diseases

Study ID

NCT06424119

Start date

Apr 26, 2024

Status verified date

May, 2024

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ICR-No Food

Intensive Cardiac Rehab (ICR) 72-session program without C2life® supplied food

experimental: ICR-Food

Intensive Cardiac Rehab (ICR_ 72-session program with C2life® supplied food

active comparator: TCR-No Food

Traditional Cardiac Rehab (TCR) 36-session program without C2life® supplied food

Interventions

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.

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.

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.

Primary outcome measure

  • Readmission Rate Data [ Time Frame: Followup may extend up to 5 years for a post-hoc EMR analysis. ]

Central Contacts and Locations

Locations

Trinity Health Ann Arbor

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Frank Smith, MD

734-712-8000fsmith@michiganheart.com

Autumn Howe, RN

(734)712-8387

Principal Investigator:

Frank A. Smith, MD

Mission Health

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Brian Asbill, MD

828-274-6000asbillbh@gmail.com

Principal Investigator:

Brian Asbill, MD

More Information

Sponsor

Pritikin ICR

Last update posted

May 21, 2024

Last verified

May, 2024

Keywords

  • Intensive Cardiac Rehabilitation
  • Traditional Cardiac Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pritikin ICR on 2024-05-21.