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

NCT06424119 | Recruiting

• 1 other identifier: CREDIBLE
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 3

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

Keywords

Intensive Cardiac Rehabilitation; Traditional Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Readmission Rate Data

  Readmission rate data will include: 1. Actual number of all cause readmissions 2. Days in hospital for each readmission 3. Cost of readmission. Stratification between all cause and cardiovascular readmissions will be performed as an additional sub-analysis.

  Followup may extend up to 5 years for a post-hoc EMR analysis.

Secondary Outcomes (6)

• MACE

  At 1 and 2 years.

• Composite Total Readmission Rates

  At 1 and 2 years

• Readmission Days

  At 1 and 2 years

• Dietary Inflammation Index (DII)

  At admission, discharge from program (about 12 weeks), and 6 month post-discharge

• Labs

  At admission, discharge (about 12 weeks), and 6 months post-discharge

Study Arms (3)

ICR-No Food

EXPERIMENTAL

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

Behavioral: Intensive Cardiac Rehabilitation

ICR-Food

EXPERIMENTAL

Intensive Cardiac Rehab (ICR\_ 72-session program with C2life® supplied food

Behavioral: Intensive Cardiac Rehabilitation; Other: C2life® Food

TCR-No Food

ACTIVE COMPARATOR

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

Behavioral: Traditional Cardiac Rehabilitation

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.

Also known as: TCR

TCR-No Food

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.

Also known as: ICR

ICR-Food; ICR-No Food

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.

ICR-Food

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Anticipated life expectancy of under 2 years
• Any co-morbidity that would limit participation in the study.

Sponsors & Collaborators

• Pritikin ICR: lead
• Ballad Health: collaborator
• Mission Health System, Asheville, NC: collaborator
• Trinity Health System: collaborator
• Connecting Health Innovation: collaborator

Study Sites (3)

Trinity Health Ann Arbor

Ypsilanti, Michigan, 48197, United States

RECRUITING

Mission Health

Asheville, North Carolina, 28803, United States

RECRUITING

Ballad CVA Heart Institute

Kingsport, Tennessee, 37660, United States

NOT YET RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Brian Asbill, MD

  Mission Health

  PRINCIPAL INVESTIGATOR

• David Beckner, MD

  Ballad Health

  PRINCIPAL INVESTIGATOR

• Frank A. Smith, MD

  Trinity Health System

  PRINCIPAL INVESTIGATOR

• James R. Hebert, ScD, MSPH

  Connecting Health Innovations, LLC (CHI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 21, 2024
• Study Start: April 26, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

US (3)