Effect of Evolocumab
Condition: Atherosclerotic cardiovascular disease, hypercholesterolemia
Key Inclusion Criteria:
- Evidence by cardiac computed tomography angiography of noncalcified coronary artery plaque and thoracic aorta atherosclerosis
- Indications for evolocumab treatment
Key Exclusion Criteria:
- Creatinine >1.5 mg/dL before imaging
- History of allergy to iodine contrast agents
- Allergy to evolocumab or any other ingredients contained in study drug
Full Study Name
Effect of Evolocumab on Coronary Artery Plaque Volume and Composition by Coronary CTA (CCTA) and Microcalcification by F18-NaF PET (IRB no. 54274)
This study focuses on patients who have clinical atherosclerotic cardiovascular disease (ASCVD) or high cholesterol levels and are allergic to statins, or who have been diagnosed with primary hypercholesterolemia or homozygous familial hypercholesterolemia (genetic disorder causing high cholesterol levels and early heart disease). The purpose of the study is to evaluate the changes, if any, in coronary plaque volumes and its composition in patients who are treated with a drug called evolocumab. To help evaluate the effect of evolocumab, researchers will ask patients who are scheduled to start taking evolocumab plus another cholesterol-lowering medication (such as a statin) to undergo diagnostic testing, including non-invasive coronary computed tomography angiography scans and positron emission tomography (PET) scans.
Evolocumab is used in patients who have high cholesterol levels despite treatment with statins (medication which lowers the fat in blood) or in those who are unable to take statins; the drug is approved by the U.S. Food and Drug Administration (FDA). The PET scan includes sodium fluoride injection, which is approved by the FDA as a diagnostic agent for bone imaging. The use of sodium fluoride in this study is investigational.