Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424119
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-12
Brief Title:
Multi-Center Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs
Sponsor:
Pritikin ICR
Organization:
Pritikin ICR
Study Overview
Official Title:
Multi-Center Randomized Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs CREDIBLE Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CREDIBLE
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None