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

Part of paid clinical trials in Ypsilanti, Michigan.

Sponsor
Pritikin ICR
Study ID
NCT06424119
Status
Recruiting
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Conditions

  • Cardiovascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Traditional Cardiac Rehabilitation — BEHAVIORAL
    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 — BEHAVIORAL
    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 — OTHER
    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.

Study Details

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

Key Dates

Start date
Apr 26, 2024
Status verified
May 2024
Primary completion
Jun 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Locations (3)

FacilityCityStateZIPSite coordinators
Trinity Health Ann ArborYpsilantiMichigan48197
Frank Smith, MD
[email protected]
734-712-8000
Autumn Howe, RN
(734)712-8387
Frank A. Smith, MD (PRINCIPAL_INVESTIGATOR)
Mission HealthAshevilleNorth Carolina28803
Brian Asbill, MD
[email protected]
828-274-6000
Brian Asbill, MD (PRINCIPAL_INVESTIGATOR)
Ballad CVA Heart InstituteKingsportTennessee37660
David Beckner, MD
[email protected]
423-230-5640
David Beckner, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Trinity Health Ann Arbor· Ypsilanti, MIMission Health· Asheville, NCBallad CVA Heart Institute· Kingsport, TN

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