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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post intervention
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 21 and 90 years old with stable heart artery disease.
Select...
I am between 21 and 90 years old with stable heart artery disease.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Biomarker Risk Score (BRS)
Change in composite complications
Secondary outcome measures
All cause death
Change in plasma levels of BNP
Change in plasma levels of hs-cTnI
+2 more

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.

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Who is running the clinical trial?

Emory UniversityLead Sponsor
1,650 Previous Clinical Trials
2,572,204 Total Patients Enrolled
29 Trials studying Coronary Artery Disease
10,895 Patients Enrolled for Coronary Artery Disease
Arshed Quyyumi, MDPrincipal InvestigatorEmory University
11 Previous Clinical Trials
1,979 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
25 Patients Enrolled for Coronary Artery Disease

Media Library

Coronary Artery Disease Research Study Groups: Optimization Group, Usual Care Group, Registry Group
~300 spots leftby Dec 2028
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