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Biomarker-based Therapy

Personalized Treatment for Coronary Artery Disease

N/A

Recruiting

Led By Arshed Quyyumi, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals aged 21-90 years with stable CAD

individuals aged 21-90 years with stable CAD.

Must not have

Congenital heart disease

Planned revascularization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years post intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a personalized treatment plan based on biomarkers can help reduce the risk of complications for people with coronary artery disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial compares standard treatments to customized ones based on individual risk profiles, side effects may vary widely but could include typical reactions to cardiovascular medications such as dizziness, headaches, bleeding risks for anticoagulants, and potential lifestyle intervention discomforts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 90 years old with stable heart artery disease.

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I am between 21 and 90 years old with stable heart artery disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was born with a heart condition.

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I am scheduled for a procedure to restore blood flow.

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I have had a heart transplant.

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I experience severe symptoms of heart failure.

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I have severe heart valve symptoms.

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I currently have cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Biomarker Risk Score (BRS)

Change in composite complications

Secondary study objectives

All cause death

Change in plasma levels of BNP

Change in plasma levels of hs-cTnI

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 8Eligibility criteria met