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NCT06424119 · ClinicalTrials.gov registry record · NA
Multi-Center Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs
A NA study of Cardiovascular Diseases, sponsored by Pritikin ICR.
- Recruiting
- Registry status
- NA
- Development phase
- 450
- Enrollment target
- 3
- Study locations
NCT06424119: Recruiting NA study of Cardiovascular Diseases, sponsored by Pritikin ICR.
NCT06424119 is a NA study of Cardiovascular Diseases that is actively recruiting participants, run by Pritikin ICR. The registered enrollment target is 450 participants, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06424119, a NA study of Cardiovascular Diseases, is actively recruiting participants, sponsored by Pritikin ICR.
- RECRUITING
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
- 3
- Study locations
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Traditional Cardiac Rehabilitation
- BEHAVIORAL Intensive Cardiac Rehabilitation
- OTHER C2life® Food
Study Locations (3)
Michigan
- Trinity Health Ann Arbor - Ypsilanti
North Carolina
- Mission Health - Asheville
Tennessee
- Ballad CVA Heart Institute - Kingsport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-04-26 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT06424119 shows while recruiting
NCT06424119 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Cardiovascular Diseases appearing as the primary indexed condition, and to 3 interventions - of which Traditional Cardiac Rehabilitation is the first listed.
NCT06424119 reports a single indexed study location in Michigan, North Carolina, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06424119 about?
NCT06424119 is a clinical study titled "Multi-Center Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs". 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 outcome...
What is the current status of trial NCT06424119?
This trial is currently recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2024-04-26. Estimated completion is 2027-12-31.
What conditions does trial NCT06424119 study?
This clinical trial studies the following conditions: Cardiovascular Diseases.
What interventions are being tested in trial NCT06424119?
The interventions under investigation include: Traditional Cardiac Rehabilitation (BEHAVIORAL), Intensive Cardiac Rehabilitation (BEHAVIORAL), C2life® Food (OTHER).
Who is sponsoring clinical trial NCT06424119?
This trial is sponsored by Pritikin ICR, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06424119 being conducted?
This trial has 3 study locations across Michigan, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiovascular Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06424119's enrollment target sits among peer trials
450 101st of 300 higher than 199 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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