REFINE-CAC is a prospective, multi-center trial assessing the management of asymptomatic participants with CAC scores 1-299 Agatston units or incidental CAC findings on chest computed tomography (CT), all of whom will undergo CCTA and are blinded to the coronary anatomy (e.g., % stenosis). The trial includes a randomized, controlled pathway and a single arm, observational registry pathway.
Calcium score between 1-299 between 3-6 months prior to Day 0 or incidental CAC findings on a chest CT between 3 to 6 months prior to Day 0
Men ≥40 and ≤79, Women ≥45 and ≤79
Patients who do not have symptoms suggestive of CAD
Visible plaque on CCTA
Symptoms suggestive of CAD (e.g. stable angina)
On PCSK9 targeted therapy (e.g. evolocumab, alirocumab, inclisiran, or enlicitide)
Reduced left ventricular ejection fraction (LVEF) <35%, if known
Prior history of ASCVD
Parallel
Heartflow Analysis
DeviceREFINE-CAC will provide Heartflow Analyses
Percentage of participants who initiate, intensify, cease, or de-escalate lipid lowering therapy (LLT)
Percentage of participants who initiate, intensify, cease, or de-escalate lipid-lowering therapy (LLT)
Percentage of participants who initiate, intensify, cease, or de-escalate medication therapy
Time to initiation, intensification, cessation, or de-escalation of LLT
Percent of participants undergoing lipid testing
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HeartFlow, Inc.
Lead sponsor
Avania
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
