ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) for Coronary Artery Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Altman Clinical and Translational Research Institute, La Jolla, CA
Coronary Artery Disease+2 More
ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a program of intensive cardiac rehabilitation can reduce levels of LDL cholesterol and improve other markers of metabolic and cardiovascular health.

See full description

Eligible Conditions

  • Coronary Artery Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Coronary Artery Disease

Study Objectives

This trial is evaluating whether ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) will improve 1 primary outcome, 3 secondary outcomes, and 1 other outcome in patients with Coronary Artery Disease. Measurement will happen over the course of Baseline and Week 9.

Baseline and Week 1-9
Change in Exercise Capacity (MetS)
Baseline and Week 9
Change in LDL cholesterol
Change in TMAO levels
Change in Triglycerides
Change in non-HDL cholesterol

Trial Safety

Safety Progress

1 of 3

Other trials for Coronary Artery Disease

Trial Design

2 Treatment Groups

ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)
1 of 2
ICR (Intensive Cardiac Rehabilitation)
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. ICR X TRE (Intensive Cardiac Rehabilitation X Time-Restricted Eating) is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)
Behavioral
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.
ICR (Intensive Cardiac Rehabilitation)
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and week 1-9
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and week 1-9 for reporting.

Who is running the study

Principal Investigator
P. T.
Prof. Pam Taub, MD
University of California, San Diego

Closest Location

Altman Clinical and Translational Research Institute - La Jolla, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs, no dose adjustments will be allowed during the study period.
Age: 18-75 years
Enrollment and planned participation in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program
Established diagnosis of coronary artery disease (concomitant systolic or diastolic HF is allowable)
Own a smartphone (Apple iOS or Android OS)

Patient Q&A Section

What causes coronary disease?

"Atherosclerosis seems to be a major risk factor for coronary disease, the likelihood being higher in individuals who have a family history of ischemic heart disease and cigarette smoking." - Anonymous Online Contributor

Unverified Answer

What is coronary disease?

"Coronary disease is a collection of coronary artery diseases, with an increased risk of heart attacks and sudden cardiac arrest. Approximately one in three Canadians have symptoms of coronary disease in their lifetime!" - Anonymous Online Contributor

Unverified Answer

How many people get coronary disease a year in the United States?

"There are significant racial and geographic disparities in the incidence of CAD. In our study, Blacks were at a lower risk than Caucasians for CAD in the first year after diagnosis with a CAD atheroma, whereas by 10 years, Whites were at a higher risk for the same type of disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for coronary disease?

"Several types of medications may be used to treat coronary disease, depending on the type of underlying disease. Cardiac rehabilitation is a commonly used treatment.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of coronary disease?

"Signs of coronary disease may vary greatly. In many patients, signs manifest earlier, and include angina, palpitations and weakness on exercise. A wide range of signs may occur in others, such as angina, dyspnea and exercise intolerance." - Anonymous Online Contributor

Unverified Answer

Can coronary disease be cured?

"Coronary disease cannot be cured, but it can be controlled and ameliorated by good treatment. Patients with uncomplicated angina may have a high survival benefit." - Anonymous Online Contributor

Unverified Answer

Is icr x tre (intensive cardiac rehabilitation x time-restricted eating) typically used in combination with any other treatments?

"ICR X TE is recommended as a second treatment modality following CABG when indicated by evidence of significant improvement with ICR X TE, particularly where the extent of surgical deficit is thought to be significant." - Anonymous Online Contributor

Unverified Answer

How serious can coronary disease be?

"[With] age, gender, socioeconomic standing, physical activity, and health-related factors associated with disease severity, the likelihood of needing the same coronary intervention or the same bypass surgery [twice or more] was approximately one-third. This high rate should alert clinicians to the relevance of cardiovascular risk factors and disease severity in patients with coronary disease." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating coronary disease?

"A substantial quantity of research has recently been published. There has also been an increase in the number of small, isolated, case-series trials being conducted around the world. This research suggests that we have made some progress towards optimizing our treatment algorithms. More work is needed into the management and optimization of beta-blocker use and the avoidance of aspirin in people with coronary disease. Large multi-center studies are required to assess whether a specific treatment protocol or regime is best for coronary disease patients worldwide. Moreover, these trials are necessary to assess the value of new new pharmacological agents for treating coronary disease." - Anonymous Online Contributor

Unverified Answer

Does coronary disease run in families?

"Even though coronary patients had a similar mean age to age of onset of first manifestations compared with the general population, the number of cases of coronary disease was significantly higher than the number of cases of first manifestations of disease. This suggests that genetic and environmental risk factors act at the same age of onset in the family. Also, the number of cases of first manifestations in each family (with premature CAD) was significantly higher. Thus, it could be concluded that the clinical presentation of CAD in the family members could be attributed to a genetic influence, and that CAD is not only a hereditary disease." - Anonymous Online Contributor

Unverified Answer

What does icr x tre (intensive cardiac rehabilitation x time-restricted eating) usually treat?

"IC RXT improved physical fitness, reduced body fat mass indexes, and increased aerobic fitness, and may also have improved autonomic modulation and endothelial function of resistance vessels. However, these benefits were not associated with improvements in lipid profile, blood pressure, or endothelial function of the conduit vessels." - Anonymous Online Contributor

Unverified Answer

Does icr x tre (intensive cardiac rehabilitation x time-restricted eating) improve quality of life for those with coronary disease?

"ICR x TRE was not found to be an effective recovery strategy for patients with coronary disease. The ICR x TRE program did not have a greater effect on QoL than ICR." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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