Cardiovascular DiseasesCREDIBLENCT06424119
Multi-Center Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs
A study testing Traditional Cardiac Rehabilitation, Intensive Cardiac Rehabilitation and C2life® Food in people with Cardiovascular Diseases, run by Pritikin ICR at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Traditional Cardiac Rehabilitation, Intensive Cardiac Rehabilitation and C2life® Food
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Apr 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Anticipated life expectancy of under 2 years
- Any co-morbidity that would limit participation in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mission Health
Asheville, North Carolina, 28803
Brian Asbill, MD, 828-274-6000, asbillbh@gmail.com
Brian Asbill, MD
- Not yet recruiting
Ballad CVA Heart Institute
Kingsport, Tennessee, 37660
David Beckner, MD, 423-230-5640, david.beckner@balladhealth.org
David Beckner, MD
- Recruiting
Trinity Health Ann Arbor
Ypsilanti, Michigan, 48197
Frank Smith, MD, 734-712-8000, fsmith@michiganheart.com
Autumn Howe, RN, (734)712-8387
About this study
Official title: Multi-Center Randomized Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs (CREDIBLE Study)
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.
Read more
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
- Cardiovascular Diseases
- Being tested
- Traditional Cardiac Rehabilitation, Intensive Cardiac Rehabilitation, C2life® Food
- Keywords
- Intensive Cardiac Rehabilitation, Traditional Cardiac Rehabilitation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Cardiac RehabilitationBehavioural
Also called TCR
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 RehabilitationBehavioural
Also called ICR
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® FoodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ICR-No Food | Experimental | Intensive Cardiac Rehab (ICR) 72-session program without C2life® supplied food Receives: Behavioral: Intensive Cardiac Rehabilitation |
| ICR-Food | Experimental | Intensive Cardiac Rehab (ICR_ 72-session program with C2life® supplied food Receives: Behavioral: Intensive Cardiac Rehabilitation; Other: C2life® Food |
| TCR-No Food | Active comparator | Traditional Cardiac Rehab (TCR) 36-session program without C2life® supplied food Receives: Behavioral: Traditional Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Followup may extend up to 5 years for a post-hoc EMR analysis.
Secondary outcomes (6)
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.
Measured: At 1 and 2 years.
Composite Total Readmission Rates
Number of readmissions within 2 years.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Buccal swab at admission and discharge (about 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start26 Apr 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pritikin ICR
- Sponsor type
- University, hospital or other
- Collaborators
- Ballad Health, Mission Health System, Asheville, NC, Trinity Health System, Connecting Health Innovation
- Responsible party
- Sponsor
- Investigators
- Brian Asbill, MD, Principal investigator, Mission HealthDavid Beckner, MD, Principal investigator, Ballad HealthFrank A. Smith, MD, Principal investigator, Trinity Health SystemJames R. Hebert, ScD, MSPH, Principal investigator, Connecting Health Innovations, LLC (CHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424119
- Sponsor's protocol ID
- CREDIBLE
- Acronym
- CREDIBLE
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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, 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.
PubMed 26673558Leon 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.
PubMed 15668354McMahon 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.
PubMed 28318815Kotseva 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.
PubMed 29873511Anderson 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.
PubMed 26764059Balady 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.
PubMed 17513578R. 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.
PubMed 32515660Wong 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.
PubMed 33715546Zhong 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.
PubMed 32941845Kiecolt-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.
PubMed 20410248Shivappa 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.
PubMed 29439509Mazidi 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.
PubMed 30015256Marx 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.
PubMed 33873204Asadi 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.
PubMed 31617677
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Randomized Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs (CREDIBLE Study)
- ClinicalTrials.gov ID
- NCT06424119
- Acronym / sponsor ID
- CREDIBLE / CREDIBLE
- Conditions
- Cardiovascular Diseases
- Keywords
- Intensive Cardiac Rehabilitation, Traditional Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Pritikin ICRUniversity, hospital or other
- Collaborators
- Ballad Health, Mission Health System, Asheville, NC, Trinity Health System, Connecting Health Innovation
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| ICR-No Food | Experimental | Behavioral: Intensive Cardiac RehabilitationIntensive Cardiac Rehab (ICR) 72-session program without C2life® supplied food |
| ICR-Food | Experimental | Behavioral: Intensive Cardiac Rehabilitation, Other: C2life® FoodIntensive Cardiac Rehab (ICR_ 72-session program with C2life® supplied food |
| TCR-No Food | Active comparator | Behavioral: Traditional Cardiac RehabilitationTraditional Cardiac Rehab (TCR) 36-session program without C2life® supplied food |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Anticipated life expectancy of under 2 years
- Any co-morbidity that would limit participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Cardiac RehabilitationAlso: TCRPatient 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. | Behavioural | TCR-No Food |
| Intensive Cardiac RehabilitationAlso: ICRPatient 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. | Behavioural | ICR-Food, ICR-No Food |
| C2life® FoodPatient 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. | Other | ICR-Food |
Primary outcome
Readmission Rate Data
Time frame: Followup may extend up to 5 years for a post-hoc EMR analysis.
Readmission rate data will include: 1. Actual number of all cause readmissions 2. Days in hospital for each readmission 3. Cost of readmission. Stratification between all cause and cardiovascular readmissions will be performed as an additional sub-analysis.
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 26673558Writing 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.
- Background: PubMed 15668354Leon 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.
- Background: PubMed 28318815McMahon 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.
- Background: PubMed 29873511Kotseva 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.
- Background: PubMed 26764059Anderson 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.
- Background: PubMed 17513578Balady 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.
- BackgroundR. James Barnard, Ph.D. The Pritikin Program: Understanding its value in Preventing and Controlling common diseases
- Background: PubMed 32515660Gomez-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.
- Background: PubMed 33715546Wong 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.
- Background: PubMed 32941845Zhong 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.
- Background: PubMed 20410248Kiecolt-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.
- Background: PubMed 29439509Shivappa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Asbill, MD principal investigator
Mission Health
David Beckner, MD principal investigator
Ballad Health
Frank A. Smith, MD principal investigator
Trinity Health System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Cardiac Rehabilitation, Intensive Cardiac Rehabilitation and C2life® Food in people with Cardiovascular Diseases, run by Pritikin ICR at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission Rate Data (time frame: Followup may extend up to 5 years for a post-hoc EMR analysis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06424119, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.