ICR + Time-Restricted Eating for Coronary Artery Disease

(TRE x ICR Trial)

Overseen By Victoria A Green, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Insulin, Appetite medications

Disqualifiers: Inflammatory disease, Tobacco use, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating within a limited number of hours each day can lower LDL cholesterol and improve heart health. Participants will either follow an Intensive Cardiac Rehabilitation program (a heart-focused rehab program) or combine it with time-restricted eating, limiting meals to a 10-hour window. The trial aims to determine if these approaches can boost exercise capability and reduce certain digestion-related substances linked to heart disease. People with coronary artery disease who are already enrolled in a specific cardiac rehab program and own a smartphone might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart health research.

Do I have to stop taking my current medications for the trial?

You don't have to stop taking your current medications, but you can't change the dose of any cardiovascular medications during the study.

What prior data suggests that Time-Restricted Eating and Intensive Cardiac Rehabilitation are safe for improving cardiovascular health?

Research has shown that Intensive Cardiac Rehabilitation (ICR) programs, such as Dr. Ornish's, are generally well-received by participants. Studies have found that these programs can improve heart health without major safety concerns, indicating that ICR is usually safe for people with heart problems.

Time-Restricted Eating (TRE) is still under investigation, particularly for its effects on heart disease. Some studies suggest that TRE can help with conditions like diabetes and high blood pressure, which are linked to heart health. However, reports indicate increased heart risks when eating is limited to short periods, such as 8 hours a day. These findings highlight the need for more research to understand the safety of TRE for people with heart disease.

In summary, while current evidence considers ICR safe, the safety of TRE for heart patients requires more careful study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intensive Cardiac Rehabilitation combined with Time-Restricted Eating (ICR x TRE) because it introduces an innovative approach to managing coronary artery disease. Traditional treatments often involve medication and lifestyle changes, but this method specifically integrates time-restricted eating, where patients limit their eating to a 10-hour window each day. This approach could optimize metabolic health and improve cardiovascular outcomes by aligning eating patterns with the body's natural circadian rhythms. By coupling this with intensive cardiac rehabilitation, the treatment aims to enhance heart health more effectively than standard methods alone, potentially offering a new, non-pharmacological strategy for patients.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

Research has shown that Intensive Cardiac Rehabilitation (ICR) can help reverse heart disease. Studies have found that ICR lowers bad cholesterol (LDL) and improves heart health. This program is supported by scientific evidence and covered by Medicare, underscoring its effectiveness. In this trial, participants will be assigned to different treatment arms. One arm will receive ICR alone, while another will combine ICR with Time-Restricted Eating (TRE). TRE may enhance the benefits of ICR by reducing daily eating hours. Early signs suggest that eating within a 10-hour window can improve metabolism, including blood sugar and blood pressure levels. Together, ICR and TRE can potentially improve heart health and increase exercise capacity. ^{1 3 5 6 7}

Who Is on the Research Team?

Pam R Taub, MD

Principal Investigator

UC San Diego Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with coronary artery disease who are enrolled in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program. Participants must be on stable doses of cardiovascular medications, own a smartphone, and not have conditions like active cancer (except non-melanoma skin cancer), inflammatory diseases, type I diabetes requiring insulin, or severe kidney disease.

Inclusion Criteria

Own a smartphone (Apple iOS or Android OS)

I am on heart or diabetes medication and cannot change the dose during the study.

I am enrolled in UC San Diego's 9-week heart rehab program.

Exclusion Criteria

I have heart failure that affects the heart's pumping ability.

You have a device supporting the left side of your heart.

I am currently in a weight-loss or management program, not including UC San Diego's Cardiac Rehab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Intensive Cardiac Rehabilitation (ICR) with or without Time-Restricted Eating (TRE) for 9 weeks

9 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for long-term cardiovascular health status after completing the ICR program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Cardiac Rehabilitation
• Time Restricted Eating

Trial Overview The study tests if Time-Restricted Eating (TRE) combined with Intensive Cardiac Rehabilitation (ICR) can improve cholesterol levels, blood sugar, blood pressure, exercise capacity and reduce TMAO levels compared to just ICR. TRE involves eating within a certain number of hours each day.

How Is the Trial Designed?

Group I: ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) Experimental Treatment 1 Intervention

20 patients will be randomly assigned to the Time-Restricted Eating (TRE) group which will be asked to limit the number of hours they eat in a day to 10 hours in addition to receiving the standard of care health and nutritional wellness guidelines that are required of UCSD's 9-week ICR program, referred to as the "ICR x TRE" group.

Group II: ICR (Intensive Cardiac Rehabilitation) Placebo Group 1 Intervention

20 patients will be randomly assigned to the standard of care group, which will receive the standard health and nutritional wellness guidelines that are required of UCSD's 9-week ICR program, referred to as the "ICR" group.

Intensive Cardiac Rehabilitation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Intensive Cardiac Rehabilitation for:

• Acute myocardial infarction
• Coronary bypass surgery
• Stable angina pectoris
• Heart valve repair or replacement
• Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
• Heart or heart-lung transplant

Approved in European Union as Intensive Cardiac Rehabilitation for:

• Myocardial infarction
• Coronary artery bypass grafting
• Stable angina
• Heart failure
• Valvular surgery
• Cardiac transplantation

Approved in Canada as Intensive Cardiac Rehabilitation for:

• Recent myocardial infarction
• Acute coronary artery syndrome
• Chronic stable angina
• Congestive heart failure
• After coronary artery bypass surgery
• After a percutaneous coronary intervention
• Valvular surgery
• Cardiac transplantation

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Salk Institute for Biological Studies

Collaborator

Trials

23

Recruited

2,200+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Citations

1. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=240&NcaName=Intensive+Cardiac+Rehabilitation+%28ICR%29+Program+-+Dr.+Ornish

NCA - Intensive Cardiac Rehabilitation (ICR) Program - Dr. ... Use this page to view details for the decision Memo for Intensive Cardiac Rehabilitation (ICR) Program - Dr. Ornish's Program for Reversing Heart Disease ...

2. ornish.com ornish.com/zine/ornish-intensive-cardiac-rehabilitation-program/

Dr. Dean Ornish's Intensive Cardiac Rehabilitation Program The Ornish Reversal Program is the first program to be covered by Medicare under the new category of Intensive Cardiac Rehabilitation.

3. aetna.com aetna.com/cpb/medical/data/200_299/0267.html

Intensive Cardiac Rehabilitation Programs Dean Ornish conducted a series of studies to ascertain if an intensive risk-modification regimen can arrest or even reverse progression of atherosclerosis. The ...

4. prc.hmsa.com prc.hmsa.com/s/article/Intensive-Cardiac-Rehabilitation-Dr-Ornish-s-Program-for-Reversing-Heart-Disease-Ornish-Lifestyle-MedicineTM

Intensive Cardiac Rehabilitation / Dr. Ornish's Program for ... Ornish Lifestyle MedicineTM is a lifestyle change program scientifically proven in leading peer-reviewed medical journals to reverse heart disease by changing ...

5. brownhealth.org brownhealth.org/centers-services/cardiac-pulmonary-vascular-rehab/intensive-program

Intensive Cardiac Rehab Program This program is the only lifestyle medicine program proven in randomized controlled clinical trials to reverse the progression of coronary heart disease.

6. uclahealth.org uclahealth.org/sites/default/files/documents/Ornish_LiteratureReview.pdf?f=90b7156a

Scientifically Proven Research for the Dr. Dean Ornish ... The purpose of this study is to test the efficacy and effectives of an intensive cardiac rehabilitation program in improving health outcomes in multiple sites.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9643589/

Benefits of the First Pritikin Outpatient Intensive Cardiac ... Conclusions: The Pritikin outpatient ICR program promoted improvements in several cardiovascular health indices. Critical next steps are to ...