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

Cardiovascular Diseases Clinical Trial

— CREDIBLE  

Official title:

Multi-Center Randomized Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs (CREDIBLE Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06424119
• Other study ID #: CREDIBLE
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Pritikin ICR
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mission Health	Asheville	North Carolina
United States	Ballad CVA Heart Institute	Kingsport	Tennessee
United States	Trinity Health Ann Arbor	Ypsilanti	Michigan

Sponsors (5)

Lead Sponsor	Collaborator
Pritikin ICR	Ballad Health, Connecting Health Innovation, Mission Health System, Asheville, NC, Trinity Health

Country where clinical trial is conducted

United States, 

References & Publications (21)

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. — View Citation

Asadi Z, Yaghooti-Khorasani M, Ghazizadeh H, Sadabadi F, Mosa-Farkhany E, Darroudi S, Shabani N, Kamel-Khodabandeh A, Bahrami A, Khorrami-Mohebbseraj MS, Heidari-Bakavoli S, Heidari-Bakavoli A, Esmaily H, Moohebati M, Oladi MR, Shivappa N, Hebert JR, Ferns GA, Ghayour-Mobarhan M. Association between dietary inflammatory index and risk of cardiovascular disease in the Mashhad stroke and heart atherosclerotic disorder study population. IUBMB Life. 2020 Apr;72(4):706-715. doi: 10.1002/iub.2172. Epub 2019 Oct 16. — View Citation

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, Physical Activity, and Metabolism; American Association of Cardiovascular and Pulmonary Rehabilitation. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2007 May 22;115(20):2675-82. doi: 10.1161/CIRCULATIONAHA.106.180945. Epub 2007 May 18. — View Citation

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. — View Citation

Kiecolt-Glaser JK. Stress, food, and inflammation: psychoneuroimmunology and nutrition at the cutting edge. Psychosom Med. 2010 May;72(4):365-9. doi: 10.1097/PSY.0b013e3181dbf489. Epub 2010 Apr 21. — View Citation

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. — View Citation

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 rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. doi: 10.1161/01.CIR.0000151788.08740.5C. Erratum In: Circulation. 2005 Apr 5;111(13):1717. — View Citation

Marx W, Veronese N, Kelly JT, Smith L, Hockey M, Collins S, Trakman GL, Hoare E, Teasdale SB, Wade A, Lane M, Aslam H, Davis JA, O'Neil A, Shivappa N, Hebert JR, Blekkenhorst LC, Berk M, Segasby T, Jacka F. The Dietary Inflammatory Index and Human Health: An Umbrella Review of Meta-Analyses of Observational Studies. Adv Nutr. 2021 Oct 1;12(5):1681-1690. doi: 10.1093/advances/nmab037. — View Citation

Mazidi M, Shivappa N, Wirth MD, Hebert JR, Mikhailidis DP, Kengne AP, Banach M. Dietary inflammatory index and cardiometabolic risk in US adults. Atherosclerosis. 2018 Sep;276:23-27. doi: 10.1016/j.atherosclerosis.2018.02.020. Epub 2018 Feb 15. — View Citation

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. — View Citation

Peterson LR, Xanthakis V, Duncan MS, Gross S, Friedrich N, Volzke H, Felix SB, Jiang H, Sidhu R, Nauck M, Jiang X, Ory DS, Dorr M, Vasan RS, Schaffer JE. Ceramide Remodeling and Risk of Cardiovascular Events and Mortality. J Am Heart Assoc. 2018 May 3;7(10):e007931. doi: 10.1161/JAHA.117.007931. — View Citation

R. James Barnard, Ph.D. The Pritikin Program: Understanding its value in Preventing and Controlling common diseases

Shivappa N, Godos J, Hebert JR, Wirth MD, Piuri G, Speciani AF, Grosso G. Dietary Inflammatory Index and Cardiovascular Risk and Mortality-A Meta-Analysis. Nutrients. 2018 Feb 12;10(2):200. doi: 10.3390/nu10020200. — View Citation

Todendi PF, Salla R, Shivappa N, Hebert JR, Ritter J, Cureau FV, Schaan BD. Association between dietary inflammatory index and cardiometabolic risk factors among Brazilian adolescents: results from a national cross-sectional study. Br J Nutr. 2022 Aug 28;128(4):744-752. doi: 10.1017/S0007114521003767. Epub 2021 Sep 21. Erratum In: Br J Nutr. 2022 Aug 28;128(4):784. — View Citation

Torgerson DJ, Roland M. What is Zelen's design? BMJ. 1998 Feb 21;316(7131):606. doi: 10.1136/bmj.316.7131.606. No abstract available. — View Citation

Wong MMH, Louie JCY. A priori dietary patterns and cardiovascular disease incidence in adult population-based studies: a review of recent evidence. Crit Rev Food Sci Nutr. 2022;62(22):6153-6168. doi: 10.1080/10408398.2021.1897517. Epub 2021 Mar 10. — View Citation

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, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available. Erratum In: Circulation. 2016 Apr 12;133(15):e599. — View Citation

Zelen M. A new design for randomized clinical trials. N Engl J Med. 1979 May 31;300(22):1242-5. doi: 10.1056/NEJM197905313002203. — View Citation

Zelen M. Alternatives to classic randomized trials. Surg Clin North Am. 1981 Dec;61(6):1425-32. doi: 10.1016/s0039-6109(16)42596-x. — View Citation

Zelen M. Randomized consent designs for clinical trials: an update. Stat Med. 1990 Jun;9(6):645-56. doi: 10.1002/sim.4780090611. — View Citation

Zhong VW, Ning H, Van Horn L, Carnethon MR, Wilkins JT, Lloyd-Jones DM, Allen NB. Diet Quality and Long-Term Absolute Risks for Incident Cardiovascular Disease and Mortality. Am J Med. 2021 Apr;134(4):490-498.e24. doi: 10.1016/j.amjmed.2020.08.012. Epub 2020 Sep 14. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission Rate Data	Readmission rate data will include: Actual number of all cause readmissions; Days in hospital for each readmission; Cost of readmission.; Stratification between all cause and cardiovascular readmissions will be performed as an additional sub-analysis.	Followup may extend up to 5 years for a post-hoc EMR analysis.
Secondary	MACE	MACE is defined as all-cause death, non-fatal MI, hospitalization for unstable angina, PCI, CABG, peripheral artery revascularization, Ischemic stroke, CHF hospitalization, heart valve surgery, and heart transplant.	At 1 and 2 years.
Secondary	Composite Total Readmission Rates	Number of readmissions within 2 years.	At 1 and 2 years
Secondary	Readmission Days	Composite length of stay in days for the total readmission events and each MACE category within 2 years.	At 1 and 2 years
Secondary	Dietary Inflammation Index (DII)	Scores will be calculated for the C2life® diet as a whole and for each participant at the prespecified measurement times.	At admission, discharge from program (about 12 weeks), and 6 month post-discharge
Secondary	Labs	Labs will include lipids, comprehensive metabolic profile, HbA1c, Hs-CRP, IL-6, TNF-alpha, IFN-gamma, and ceramides.	At admission, discharge (about 12 weeks), and 6 months post-discharge
Secondary	Epigenetic Biomarkers Performed by Prosper eDNA®	Buccal swab samples will be taken to obtain this data. We propose to use a set of epigenetic biomarkers to measure biological age, metabolic health, inflammation, and overall fitness.	Buccal swab at admission and discharge (about 12 weeks)