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| Name | Class |
|---|---|
| Ballad Health | OTHER |
| Mission Health System, Asheville, NC | OTHER |
| Trinity Health System | INDUSTRY |
| Connecting Health Innovation |
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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:
ICR-eligible participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICR-No Food | Experimental | Intensive Cardiac Rehab (ICR) 72-session program without C2life® supplied food |
|
| ICR-Food | Experimental | Intensive Cardiac Rehab (ICR_ 72-session program with C2life® supplied food |
|
| TCR-No Food | Active Comparator | Traditional Cardiac Rehab (TCR) 36-session program without C2life® supplied food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Cardiac Rehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission Rate Data | Readmission rate data will include:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Composite Total Readmission Rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Asbill, MD | Mission Health | Principal Investigator |
| David Beckner, MD | Ballad Health | Principal Investigator |
| Frank A. Smith, MD | Trinity Health System | Principal Investigator |
| James R. Hebert, ScD, MSPH | Connecting Health Innovations, LLC (CHI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Health Ann Arbor | Recruiting | Ypsilanti | Michigan | 48197 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26673558 | Background | 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. | |
| 15668354 |
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| OTHER |
ICR-eligible patients are randomized into one of three groups of 150 patients: (1) ICR 72 session program with C2life® supplied food, (2) ICR 72 session without C2life® supplied food, or (3) TCR 36 session program without C2life supplied food (ICR-food, ICR-no food, and TCR-no food).
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|
| Intensive Cardiac Rehabilitation | Behavioral | 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. |
|
|
| C2life® Food | Other | 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. |
|
Number of readmissions within 2 years. |
| At 1 and 2 years |
| 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 |
| 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 |
| 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 |
| 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) |
| Mission Health | Recruiting | Asheville | North Carolina | 28803 | United States |
|
| Ballad CVA Heart Institute | Not yet recruiting | Kingsport | Tennessee | 37660 | United States |
|
| Background |
| 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. |
| 28318815 | Background | 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. |
| 29873511 | Background | 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. |
| 26764059 | Background | 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. |
| 17513578 | Background | 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. |
| Background | R. James Barnard, Ph.D. The Pritikin Program: Understanding its value in Preventing and Controlling common diseases |
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| 20410248 | Background | 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. |
| 29439509 | Background | 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. |
| 30015256 | Background | 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. |
| 33873204 | Background | 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. |
| 31617677 | Background | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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