What side effects are associated with this type of intervention?

Common treatments for Coronary Artery Disease (CAD) include statins and PCSK9 inhibitors. Statins can cause muscle pain, liver enzyme abnormalities, and rarely, muscle damage. PCSK9 inhibitors, such as evolocumab and alirocumab, may cause mild injection site reactions, hypersensitivity reactions, and a small risk of neurocognitive symptoms. Both treatments are effective in lowering LDL cholesterol and reducing cardiovascular events but require monitoring for these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Coronary Artery Disease (CAD) that focus on lowering LDL cholesterol, a key factor in managing CAD risk. Statins, such as atorvastatin and rosuvastatin, are widely used for their efficacy in reducing LDL cholesterol levels. Additionally, PCSK9 inhibitors like evolocumab and alirocumab have been approved for patients who require further LDL reduction despite maximally tolerated statin therapy. These treatments, along with lifestyle modifications such as diet and exercise, form the cornerstone of CAD management.

What other types of research exist?

Promising novel alternatives for CAD patients in 2024 include: 1) Long-term treatment with evolocumab or alirocumab, which are PCSK9 inhibitors shown to be effective in reducing LDL cholesterol levels. 2) Evinacumab, another lipid-lowering agent, particularly beneficial for patients with homozygous familial hypercholesterolemia. 3) The use of a polypill strategy, which combines multiple cardiovascular medications to improve adherence and reduce cardiovascular events. These alternatives offer effective pharmacological options beyond traditional lifestyle modifications.

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Genetic Test Disclosure for Coronary Artery Disease (PROACT 1 Trial)

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Males and females between 40 and 75 years of age capable and willing to provide informed consent

Participant has high CAD PRS as defined on a clinical test

Must not have

Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease

Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if telling middle-aged people with high genetic risk for heart disease about their risk helps them improve their heart health.

Who is the study for?

This trial is for men and women aged 40-75 who have a high genetic risk for coronary artery disease but no history of cardiovascular diseases, severe liver or kidney conditions, or are on certain drugs. Pregnant or breastfeeding women and those with extreme obesity (BMI ≥ 40 kg/m2) are excluded.

What is being tested?

The study tests the effect of informing participants about their high genetic risk for coronary artery disease to see if this knowledge leads to improved heart health over one year.

What are the potential side effects?

Since the intervention involves only disclosing information about genetic risk, there are no direct physical side effects associated with typical medical treatments.

Eligibility Criteria

Inclusion Criteria

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

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I am between 40 and 75 years old and can give my consent.

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My clinical test shows I have a high risk for coronary artery disease.

Exclusion Criteria

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

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I have a history of heart or blood vessel disease.

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I am pregnant, breastfeeding, or might become pregnant during the study.

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My BMI is 40 or higher.

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My kidney function is reduced, with low filtration rates or high creatinine.

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I am unable to understand and give consent for treatment.

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I am not taking strong CY2P inhibitors like ketoconazole.

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I have liver disease or my recent liver tests are much higher than normal.

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I cannot hold my breath for 10 seconds.

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I am currently on medication to lower my LDL cholesterol or for inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants will receive their high polygenic risk result for coronary artery disease.

Group II: ControlActive Control1 Intervention

Participants will receive standard of care, and disclosure of high polygenic risk result will be deferred until study completion.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Coronary Artery Disease (CAD) include lifestyle modifications and pharmacological interventions. Lifestyle changes such as smoking cessation, dietary adjustments, and regular exercise help reduce risk factors like hypertension, hypercholesterolemia, and obesity. Pharmacological treatments often involve statins to lower LDL cholesterol, antiplatelet agents like aspirin to prevent clot formation, and ACE inhibitors to manage blood pressure. These treatments are essential for CAD patients as they address the underlying risk factors and prevent the progression of atherosclerosis, thereby reducing the risk of myocardial infarction and other cardiovascular events.

Failure to achieve recommended LDL cholesterol levels by suboptimal statin therapy relates to elevated cardiac event rates.Examination of lower targets for low-density lipoprotein cholesterol and blood pressure in diabetes--the Stop Atherosclerosis in Native Diabetics Study (SANDS).