Personalized Treatment for Coronary Artery Disease

Not currently recruiting at 4 trial locations

Overseen By Joey Freshwater

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Heart failure, Pregnancy, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if personalized treatments can reduce complications for people with Coronary Artery Disease (CAD), a condition that can cause chest pain and increase heart attack risk. Participants will join different groups to receive either a tailored treatment plan or standard care. The tailored plan will focus on specific health goals, such as lowering cholesterol and improving exercise habits. Individuals with stable CAD and significant artery narrowing might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could shape future CAD treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that personalized treatments for coronary artery disease (CAD) are being developed to improve patient outcomes by tailoring therapies to individual biological information. However, the sources provided offer limited direct information on the safety of these personalized treatments.

The trial under consideration is marked as "Not Applicable" for its phase, indicating it might be in the early stages of research. This often means that complete safety data may not yet be available. Nonetheless, the trial's progression suggests some confidence in its safety.

For similar personalized CAD treatments involving medication and lifestyle changes, studies have generally found these methods to be well-tolerated. They typically focus on managing cholesterol, blood sugar, and blood pressure, while promoting healthy lifestyle habits. These approaches are generally considered safe, as they adhere to standard medical guidelines for managing CAD.

While specific side effects are not detailed, the personalized approach aims to reduce risks by closely monitoring and adjusting treatments based on each person's specific needs. Prospective participants should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a personalized approach to treating coronary artery disease (CAD), aiming to optimize patient outcomes by tailoring both pharmacological and lifestyle interventions. Unlike the standard of care, which typically involves a one-size-fits-all approach with medications like statins, beta-blockers, or ACE inhibitors, this trial focuses on achieving specific health targets such as lower LDL cholesterol, controlled blood pressure, and healthy lifestyle habits. By customizing treatment plans to meet individual patient goals, the trial holds promise for more effective management of CAD, potentially leading to better long-term cardiovascular health.

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

Research has shown that personalized treatment based on a patient's unique biological information can significantly improve health for those with coronary artery disease (CAD). In this trial, participants in the Optimization Group will receive customized treatments to achieve specific health goals, such as lowering LDL-C levels and managing blood pressure, through both pharmacological and lifestyle interventions. This approach uses genetic and clinical data to tailor therapy, aiming to reduce certain proteins in the blood linked to a higher risk of heart problems. Lowering these proteins may reduce the risk of complications like heart attacks. Overall, evidence suggests that personalized treatment could be more effective than standard care, which participants in the Usual Care Group will receive, in managing CAD. ^{1 2 3 6 7}

Who Is on the Research Team?

Arshed Quyyumi, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Registry Group Experimental Treatment 1 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 Group Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers of cardiac disease. Marian, AJ., Nambi, V.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group sequential designs for developing and testing biomarker-guided personalized therapies in comparative effectiveness research. Lai, TL., Liao, OY., Kim, DW.[2021]

Personalized medicine uses an individual's unique biological information to enhance treatment for vascular diseases, but implementing this approach in clinical practice is still challenging.

Recent advancements in pharmacogenomics and vascular biology allow for better customization of four key drug classes in vascular medicine, with ongoing clinical trials needed to compare these personalized strategies against standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized vascular medicine: individualizing drug therapy. Degoma, EM., Rivera, G., Lilly, SM., et al.[2022]

In a review of 147 clinical trials for cardiovascular disease (CVD), only 1 trial (less than 1%) used a genomic biomarker prospectively to enhance patient selection, despite 32% of drug targets having relevant genetic evidence.

Almost half (46%) of the trials indicated exploratory use of biomarkers, suggesting a significant opportunity to improve drug development efficiency by better integrating genetic knowledge into clinical trial designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Overview of Genomic Biomarker Use in Cardiovascular Disease Clinical Trials. Adeniyi, O., Ramamoorthy, A., Schuck, R., et al.[2021]

Acute coronary syndromes (ACS) are a major cause of death worldwide, and precision medicine is being used to tailor treatments based on individual patient characteristics, improving outcomes.

Current precision treatments for ACS include immediate coronary revascularization for ST-segment elevation, early coronary angiography for elevated troponins, and personalized antithrombotic therapy based on bleeding risk, highlighting the need for more detailed analyses of patient data to enhance treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Phenomapping of Acute Coronary Syndromes to Improve Patient Outcomes. Andreotti, F., Iervolino, A., Navarese, EP., et al.[2021]

Genetic differences among individuals can significantly affect how they respond to medications, influencing both the effectiveness and potential side effects of treatments.

In cardiovascular medicine, pharmacogenomic factors have been linked to important drug responses, such as the risk of thrombosis with clopidogrel and the appropriate dosing of warfarin, highlighting the need for personalized medicine approaches in clinical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applied pharmacogenomics in cardiovascular medicine. Weeke, P., Roden, DM.[2021]

Personalized management of cardiovascular disorders (CVD) utilizes various 'omics' technologies and molecular diagnostics to tailor treatments based on individual patient profiles, improving the effectiveness of interventions.

A systems biology approach helps in risk stratification and treatment modeling, allowing for individualized recommendations that consider genetic and epigenetic factors, ultimately enhancing patient care in conditions like heart failure and hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Management of Cardiovascular Disorders. Jain, KK.[2018]

Using electronic health records from 21,460 patients, a new personalized algorithm called ML4CAD was developed, which significantly improves health outcomes for managing Coronary Artery Disease (CAD) by predicting adverse events with an 81.5% accuracy.

The ML4CAD algorithm increases the expected time from diagnosis to adverse events by 24.11%, particularly benefiting male and Hispanic patients, and provides physicians with an interactive tool for personalized treatment recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized treatment for coronary artery disease patients: a machine learning approach. Bertsimas, D., Orfanoudaki, A., Weiner, RB.[2021]

Coronary artery disease (CAD) continues to be the leading cause of death globally, despite advances in prevention and treatment strategies that have reduced cardiovascular mortality.

Personalized medicine, which considers individual patient factors beyond standard clinical presentations, is shown to be more effective than generic treatment approaches, highlighting the importance of tailored risk scoring systems for better clinical decision-making in CAD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Stratification in Patients with Coronary Artery Disease: A Practical Walkthrough in the Landscape of Prognostic Risk Models. Buccheri, S., D'Arrigo, P., Franchina, G., et al.[2023]

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