Coronary Artery Disease Clinical Trial
Official title:
Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
The purpose of this study is to evaluate the effect medication on your heart. All patients between 18-80 years of age, at intermediate or high risk for coronary heart disease (calculated based on age, gender, race, and history of smoking, diabetes, high blood pressure, high cholesterol, family history of early coronary heart disease) with/without symptoms suggestive of heart disease, including chest pain or shortness of breath on exertion, will be selected to take part in this study. CT scan will be used to assess to see if the prescribed treatment changes the blood vessels in heart. The investigators are doing this study because they want to develop better tools to predict, diagnose, and treat coronary heart disease. This research will help improve care for patients with coronary heart disease by evaluating heart vessel narrowing and improving the decision-making for treatment.
This is an observational study on what happens to the heart vessels after taking the FDA approved medicines prescribed by doctor to the participant. After an initial CT-scan performed for the evaluation of narrowing or blockages in the heart vessels, the investigators will enroll the participant into the study and start collecting medical history, laboratory test information and results. Patients will be randomly divided (like flipping a coin) into 2 groups - standard of care (SOC) or aggressive therapy arm (AT). If the participant is assigned to the AT group, a cardiologist will use FDA-approved drugs to reduce cholesterol and cardiovascular risk. If the participant is assigned to the SOC group, the participant will receive routine care as per participant's cardiologist. The doctor will prescribe medications that they choose themselves. The medications are not determined by participant's participation in this research. Both groups will receive dietary and lifestyle interventions. After 18 months of medical treatment, a repeat CT scan of heart will performed to check if the treatment prescribed by the study doctor changes the heart blood vessels. Participant will have about 4 tablespoons of blood drawn from a vein in the arm at the start of the study and then at 9 and 18 months. Specimens will be de-identified and tested for genetic sequencing, cholesterol and inflammatory markers. Afterwards, participant will be followed up with the cardiologist as required for your routine medical care and clinical data will be collected for 5 years. ;
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