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RECRUITING NA

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

NCT06424119 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 450 participants
Start Date 2024-04-26
Est. Completion 2027-12-31
Phase NA

Sponsor

Pritikin ICR

28 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06424119

The ClinicalTrials.gov registry entry for NCT06424119 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pritikin ICR, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06424119 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Michigan, North Carolina, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06424119?

The interventions under investigation include: Traditional Cardiac Rehabilitation (BEHAVIORAL), Intensive Cardiac Rehabilitation (BEHAVIORAL), C2life® Food (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06424119?

This trial is sponsored by Pritikin ICR, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial