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

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

Interventions

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.

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

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.

Sponsors & Collaborators

• Ballad Health

  collaborator OTHER

• Mission Health System, Asheville, NC

  collaborator OTHER

• Trinity Health System

  collaborator INDUSTRY

• Connecting Health Innovation

  collaborator OTHER

• Pritikin ICR

  lead OTHER

Principal Investigators

• Brian Asbill, MD · Mission Health

• David Beckner, MD · Ballad Health

• Frank A. Smith, MD · Trinity Health System

• James R. Hebert, ScD, MSPH · Connecting Health Innovations, LLC (CHI)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-26

Primary Completion

2026-06-30

Completion

2027-12-31

Countries

• United States

Study Locations