Trials
Search / Trial NCT06424119

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

Launched by PRITIKIN ICR · May 15, 2024

Trial Information

Current as of February 14, 2025

Recruiting

Keywords

Intensive Cardiac Rehabilitation Traditional Cardiac Rehabilitation

ClinConnect Summary

This clinical trial is examining two different types of cardiac rehabilitation programs for patients with heart conditions. The main aim is to see if an Intensive Cardiac Rehabilitation (ICR) program, which includes more sessions and a special food delivery service, leads to better health outcomes compared to a Traditional Cardiac Rehabilitation (TCR) program, which has fewer sessions. Researchers want to find out if the ICR program can reduce hospital readmissions, lower the occurrence of serious heart-related events, and improve various health markers in patients.

To participate, you need to be eligible for the ICR program and have had a specific heart-related event, such as a heart attack or heart surgery. Participants will be randomly assigned to one of three groups: one will receive the full ICR program with food, another will get the ICR program without food, and the last group will follow the TCR program. Throughout the study, participants will have their health measured at different points to track improvements. If you're interested in this trial, it’s important to note that those with a life expectancy of less than two years or certain health issues may not be eligible.

Gender

ALL

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.

Trial Officials

Brian Asbill, MD

Principal Investigator

Mission Health

David Beckner, MD

Principal Investigator

Ballad Health

Frank A. Smith, MD

Principal Investigator

Trinity Health System

James R. Hebert, ScD, MSPH

Principal Investigator

Connecting Health Innovations, LLC (CHI)

About Pritikin Icr

Pritikin ICR is a leading clinical trial sponsor dedicated to advancing research in lifestyle medicine and chronic disease prevention. With a focus on evidence-based interventions, Pritikin ICR conducts rigorous clinical trials to evaluate the efficacy of comprehensive lifestyle programs, including nutrition, exercise, and behavioral modification. Committed to improving health outcomes and enhancing quality of life, the organization collaborates with top-tier researchers and healthcare professionals to contribute valuable insights to the field of preventive health. Through its innovative approach and dedication to patient-centered care, Pritikin ICR aims to transform the landscape of healthcare and empower individuals to achieve lasting wellness.

Locations

Kingsport, Tennessee, United States

Ypsilanti, Michigan, United States

Asheville, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0