450 Participants Needed

Personalized Treatment for Coronary Artery Disease

Recruiting at 4 trial locations
JF
Overseen ByJoey Freshwater
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for coronary artery disease?

Research shows that personalized medicine, which includes tailoring treatments based on individual characteristics like genetics and biomarkers, can improve patient outcomes. Although the cardiovascular field has not widely used genetic markers, using prognostic variables to identify likely responders has been a common practice, suggesting potential benefits for personalized treatment in coronary artery disease.12345

Is personalized treatment for coronary artery disease safe?

The safety of personalized treatment for coronary artery disease is not directly addressed in the available research articles. However, personalized medicine aims to tailor treatments to individual patients, potentially reducing adverse reactions by considering genetic and other personal factors.15678

How is the personalized treatment for coronary artery disease different from other treatments?

This personalized treatment for coronary artery disease uses a patient's unique biological information, such as genetic and clinical data, to tailor therapy specifically for them, unlike standard treatments that follow a one-size-fits-all approach. It leverages machine learning models to predict and improve health outcomes by identifying the best therapy for each individual, potentially extending the time before adverse events occur.146910

What is the purpose of this trial?

People with Coronary Artery Disease (CAD) have narrow or blocked arteries that supply blood to the heart. Reduced blood flow to the heart muscle from CAD can cause chest pain or aching, especially with exercise or activity. CAD can lead to weakening of the heart muscle or heart failure, and a higher risk of heart attack or death. Certain proteins in the blood, known as biomarkers, can be found in people with CAD. Higher levels of these biomarkers are associated with a greater risk of complications from CAD. The purpose of this study is to see if a customized treatment based on biomarkers will reduce the biomarker levels and lead to lower risk of complications from CAD.

Research Team

AQ

Arshed Quyyumi, MD

Principal Investigator

Emory University

Eligibility Criteria

Adults aged 21-90 with stable Coronary Artery Disease (CAD) or those who've had recent heart treatments can join. They must have certain levels of calcium in their arteries or visible atherosclerosis. Excluded are pregnant individuals, those planning heart procedures, severe heart failure patients, transplant recipients, and active cancer patients.

Inclusion Criteria

Your calcium levels in the blood are very high, at 400 or more.
I had heart surgery or a heart attack and it's been weeks since my treatment.
You have blockages in your heart blood vessels shown on a special heart imaging test.
See 2 more

Exclusion Criteria

I was born with a heart condition.
Your heart's pumping function is less than 40%.
I am scheduled for a procedure to restore blood flow.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive customized treatment based on biomarker levels, including medication adjustments and lifestyle changes

1 year
Regular visits for physical exams, blood tests, and questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurements of BRS and adverse events

5 years
Follow-up visits at 1, 3, 6, 9 months and annually up to 5 years

Treatment Details

Interventions

  • Customized Treatment
Trial Overview The trial is testing if personalized treatment based on blood protein levels (biomarkers) can lower these biomarker levels and reduce complications from CAD. It involves comparing standard care with a tailored medical/behavioral approach guided by the patient's specific biomarker profile.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Registry GroupExperimental Treatment1 Intervention
Participants with BRS of 0 at baseline and after 3 months will undergo follow-up including measurements of BRS at the time-points specified for the randomized subjects and also for adverse events. Laboratory results and questionnaire data will be obtained on the phone.
Group II: Optimization GroupExperimental Treatment1 Intervention
Participants with CAD and a BRS greater than 0 who are randomized to the Optimization Group have treatment goals that include achieving LDL-C\<70 mg/dL, hemoglobin A1c \<7%, blood pressure \<130/80 mmHg, smoking cessation, at least 30 minutes of moderate-intensity aerobic activity 5 days a week and weight loss to body mass index \<30 kg/m2. To achieve these goals, both pharmacological and lifestyle interventions will be considered and individualized for each patient.
Group III: Usual Care GroupActive Control1 Intervention
Participants with CAD and a BRS greater than 0 who are randomized to the usual care group will receive standard of care therapy prescribed by their primary care physician and/or cardiologist. Patients and their physicians will be informed that their BRS is ≥1 and they have been randomized to the usual care group.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Findings from Research

Personalized medicine aims to tailor treatments based on individual patient characteristics, including genetic and demographic factors, to improve efficacy and reduce adverse reactions, particularly in cardiovascular disease.
The development of biomarker-based approaches in cardiovascular medicine has been challenging due to the complexity of diseases like heart failure, but better disease classification and understanding of individual variations could lead to more effective targeted therapies.
Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.Blaus, A., Madabushi, R., Pacanowski, M., et al.[2019]
Biomarker-guided personalized therapies have the potential to enhance drug development and patient care, but they also create challenges in designing effective clinical trials.
The paper introduces new group sequential designs that can be used to develop and test personalized treatment strategies with approved therapies, aiming to improve the validation process for these innovative approaches.
Group sequential designs for developing and testing biomarker-guided personalized therapies in comparative effectiveness research.Lai, TL., Liao, OY., Kim, DW.[2021]
Advancements in molecular genetics and biology are enabling the identification of numerous biomarkers for cardiovascular diseases, which can help in assessing disease risk, severity, and tailoring individual therapies.
Despite the rapid expansion of potential biomarkers, the field is still developing, and large-scale clinical studies are necessary to confirm their effectiveness in diagnosing and treating cardiovascular conditions.
Biomarkers of cardiac disease.Marian, AJ., Nambi, V.[2015]

References

Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective. [2019]
Group sequential designs for developing and testing biomarker-guided personalized therapies in comparative effectiveness research. [2021]
Biomarkers of cardiac disease. [2015]
Personalized vascular medicine: individualizing drug therapy. [2022]
Applied pharmacogenomics in cardiovascular medicine. [2021]
Personalized treatment for coronary artery disease patients: a machine learning approach. [2021]
An Overview of Genomic Biomarker Use in Cardiovascular Disease Clinical Trials. [2021]
Precision Phenomapping of Acute Coronary Syndromes to Improve Patient Outcomes. [2021]
Personalized Management of Cardiovascular Disorders. [2018]
Risk Stratification in Patients with Coronary Artery Disease: A Practical Walkthrough in the Landscape of Prognostic Risk Models. [2023]
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