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)

Overview

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

Interventions

• Behavioral Traditional Cardiac Rehabilitation
  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.
• Behavioral Intensive Cardiac Rehabilitation
  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.
• Other C2life® Food
  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.

Primary outcome measures

• Readmission Rate Data [Time frame: Followup may extend up to 5 years for a post-hoc EMR analysis.]

Secondary outcome measures (6)

• MACE [Time frame: At 1 and 2 years.]
• Composite Total Readmission Rates [Time frame: At 1 and 2 years]
• Readmission Days [Time frame: At 1 and 2 years]
• Dietary Inflammation Index (DII) [Time frame: At admission, discharge from program (about 12 weeks), and 6 month post-discharge]
• Labs [Time frame: At admission, discharge (about 12 weeks), and 6 months post-discharge]
• Epigenetic Biomarkers Performed by Prosper eDNA® [Time frame: Buccal swab at admission and discharge (about 12 weeks)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 3 centers

• Trinity Health Ann Arbor — Ypsilanti
• Mission Health — Asheville
• Ballad CVA Heart Institute — Kingsport

Publications

• Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, PMID 26673558
• Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac reh PMID 15668354
• McMahon SR, Ades PA, Thompson PD. The role of cardiac rehabilitation in patients with heart disease. Trends Cardiovasc Med. 2017 Aug;27(6):420-425. doi: 10.1016/j.tcm.2017.02.005. Epub 2017 Feb 15. PMID 28318815
• Kotseva K, Wood D, De Bacquer D; EUROASPIRE investigators. Determinants of participation and risk factor control according to attendance in cardiac rehabilitation programmes in coronary patients in Europe: EUROASPIRE IV survey. Eur J Prev Cardiol. 2018 Aug;25(12):1242-1251. doi: 10.1177/2047487318781359. Epub 2018 Jun 6. PMID 29873511
• Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044. PMID 26764059
• Balady GJ, Williams MA, Ades PA, Bittner V, Comoss P, Foody JM, Franklin B, Sanderson B, Southard D; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Epidemiology and Prevention; American Heart Association Council on Nutrition PMID 17513578
• R. James Barnard, Ph.D. The Pritikin Program: Understanding its value in Preventing and Controlling common diseases
• Gomez-Delgado F, Katsiki N, Lopez-Miranda J, Perez-Martinez P. Dietary habits, lipoprotein metabolism and cardiovascular disease: From individual foods to dietary patterns. Crit Rev Food Sci Nutr. 2021;61(10):1651-1669. doi: 10.1080/10408398.2020.1764487. Epub 2020 Jun 9. PMID 32515660

Identifiers

NCT: NCT06424119 · CREDIBLE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗