## Protocol Section
### Identification Module
**NCT ID:** NCT06424119

**Acronym:** CREDIBLE

**Brief Title:** Multi-Center Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs

**Official Title:** Multi-Center Randomized Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs (CREDIBLE Study)

#### Organization Study ID Info
**ID:** CREDIBLE
#### Organization
**Class:** OTHER
**Full Name:** Pritikin ICR
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-26

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Ballad Health

**Class:** OTHER

**Name:** Mission Health System, Asheville, NC

**Class:** UNKNOWN

**Name:** Trinity Health

**Class:** OTHER

**Name:** Connecting Health Innovation

#### Lead Sponsor

**Class:** OTHER

**Name:** Pritikin ICR

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Cardiovascular Diseases

**Keywords:**

- Intensive Cardiac Rehabilitation

- Traditional Cardiac Rehabilitation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**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).

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 450

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Intensive Cardiac Rehabilitation

**Label:** ICR-No Food

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Intensive Cardiac Rehabilitation

- Other: C2life® Food

**Label:** ICR-Food

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Behavioral: Traditional Cardiac Rehabilitation

**Label:** TCR-No Food

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TCR-No Food

**Description:** 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.

**Name:** Traditional Cardiac Rehabilitation

**Other Names:**

- TCR

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- ICR-Food

- ICR-No Food

**Description:** 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.

**Name:** Intensive Cardiac Rehabilitation

**Other Names:**

- ICR

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- ICR-Food

**Description:** 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.

**Name:** C2life® Food

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Readmission Rate Data

**Time Frame:** Followup may extend up to 5 years for a post-hoc EMR analysis.

#### Secondary Outcomes

**Description:** MACE is defined as all-cause death, non-fatal MI, hospitalization for unstable angina, PCI, CABG, peripheral artery revascularization, Ischemic stroke, CHF hospitalization, heart valve surgery, and heart transplant.

**Measure:** MACE

**Time Frame:** At 1 and 2 years.

**Description:** Number of readmissions within 2 years.

**Measure:** Composite Total Readmission Rates

**Time Frame:** At 1 and 2 years

**Description:** Composite length of stay in days for the total readmission events and each MACE category within 2 years.

**Measure:** Readmission Days

**Time Frame:** At 1 and 2 years

**Description:** Scores will be calculated for the C2life® diet as a whole and for each participant at the prespecified measurement times.

**Measure:** Dietary Inflammation Index (DII)

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

**Description:** Labs will include lipids, comprehensive metabolic profile, HbA1c, Hs-CRP, IL-6, TNF-alpha, IFN-gamma, and ceramides.

**Measure:** Labs

**Time Frame:** At admission, discharge (about 12 weeks), and 6 months post-discharge

**Description:** Buccal swab samples will be taken to obtain this data. We propose to use a set of epigenetic biomarkers to measure biological age, metabolic health, inflammation, and overall fitness.

**Measure:** Epigenetic Biomarkers Performed by Prosper eDNA®

**Time Frame:** Buccal swab at admission and discharge (about 12 weeks)

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ypsilanti

**Contacts:**

***Contact 1:***

- **Email:** fsmith@michiganheart.com

- **Name:** Frank Smith, MD

- **Phone:** 734-712-8000

- **Role:** CONTACT

***Contact 2:***

- **Name:** Autumn Howe, RN

- **Phone:** (734)712-8387

- **Role:** CONTACT

***Contact 3:***

- **Name:** Frank A. Smith, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Trinity Health Ann Arbor

**State:** Michigan

**Status:** RECRUITING

**Zip:** 48197

**Location 2:**

**City:** Asheville

**Contacts:**

***Contact 1:***

- **Email:** asbillbh@gmail.com

- **Name:** Brian Asbill, MD

- **Phone:** 828-274-6000

- **Role:** CONTACT

***Contact 2:***

- **Name:** Brian Asbill, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Mission Health

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 28803

**Location 3:**

**City:** Kingsport

**Contacts:**

***Contact 1:***

- **Email:** david.beckner@balladhealth.org

- **Name:** David Beckner, MD

- **Phone:** 423-230-5640

- **Role:** CONTACT

***Contact 2:***

- **Name:** David Beckner, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Ballad CVA Heart Institute

**State:** Tennessee

**Status:** NOT_YET_RECRUITING

**Zip:** 37660

#### Overall Officials

**Official 1:**

**Affiliation:** Mission Health

**Name:** Brian Asbill, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Ballad Health

**Name:** David Beckner, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Trinity Health

**Name:** Frank A. Smith, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Connecting Health Innovations, LLC (CHI)

**Name:** James R. Hebert, ScD, MSPH

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

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## Derived Section

### Condition Browse Module - Meshes

- ID: D000002318

- Term: Cardiovascular Diseases

### Misc Info Module

- Version Holder: 2024-05-31
