REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease

Korábbi kezelés

• Prior coronary artery bypass graft (CABG)
• Prior stents in 2+ vessel territories
• Previously evaluated with and/or in a trial which includes AI-CPA
• Active chemotherapy and/or radiation
  • Imaging Based (all to be assessed by CCTA core lab)

Más betegség

• Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)
• Enrolled in an investigational trial that involves a non-approved cardiac drug or device
• Any condition that might interfere with trial procedures or follow up visits
• Incidental findings requiring immediate follow-up or management (e.g., Aortic dissection, findings suggestive of cancer, pulmonary embolism)

Laborértékek

• Reduced left ventricular ejection fraction (LVEF) <35%, if known
• LDL-C <70 mg/dL at baseline lab draw

Egyéb

• Non-imaging based
• On PCSK9i and/or inclisiran at baseline
• Life expectancy less than 2 years due to non-CV comorbidities
• Left Main (LM) ≥50% stenosis on baseline CCTA
• Proximal LAD FFRct <0.75
• Total occlusions in major vessels and/or total occlusion in stent
• No visible plaque in non-stented segments on CCTA
• Findings that require further imaging follow-up within 1 year (e.g., pulmonary nodules ≥6 mm)

• History of PCI (1 year - 5 years prior to Day 0) and/or history of MI (Type I or II) (1 year - 5 years prior to Day 0)
• Patients who do not exhibit symptoms suggestive of CAD
• No other clinical CCTA subsequent to MI/PCI but prior to screening
• eGFR >45 mL/min per most recent measurement within 90 days
• Willingness to comply with all aspects of the protocol including research CCTAs, lab draws, medication adherence assessments, attending all study visits, and the ability to comply with prescribed medications
• For a female participant of childbearing potential (those who have not been surgically sterilized), a pregnancy test must be performed with negative results known within 7 days prior to randomization
• Ability to provide informed consent
• Visible plaque in non-stented region on CCTA as assessed by CCTA core lab
• Acceptable CCTA quality per Heartflow acceptance criteria