NCT07834372尚未招募不适用
Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
研究概览
简要总结
REWRITE-CAD is a prospective, randomized, multi-center trial assessing the management of asymptomatic participants with a history of PCI or MI who will undergo a blinded CCTA and be randomly assigned to either the test arm in which participants receive the unblinded results of Heartflow AI-CPA or the usual care arm in which participants are blinded to the AI-CPA results.
详细描述
The objective of the REWRITE-CAD trial is to assess changes in lipid lowering therapy over time in participants with a history of PCI or MI who undergo a blinded CCTA and are randomly assigned to either the test arm in which participants will undergo a blinded CCTA and receive the unblinded Heartflow AI-CPA results or the usual care arm in which participants will undergo a blinded CCTA with blinded AI-CPA results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Non-imaging based
- •Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)
- •On PCSK9i and/or inclisiran at baseline
- •Reduced left ventricular ejection fraction (LVEF) <35%, if known
- •Prior coronary artery bypass graft (CABG)
- •Prior stents in 2+ vessel territories
- •Life expectancy less than 2 years due to non-CV comorbidities
- •Enrolled in an investigational trial that involves a non-approved cardiac drug or device
- •Previously evaluated with and/or in a trial which includes AI-CPA
- •Any condition that might interfere with trial procedures or follow up visits
- •LDL-C <70 mg/dL at baseline lab draw
- •Active chemotherapy and/or radiation
- •Imaging Based (all to be assessed by CCTA core lab)
- •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
- •Incidental findings requiring immediate follow-up or management (e.g., Aortic dissection, findings suggestive of cancer, pulmonary embolism)
- •Findings that require further imaging follow-up within 1 year (e.g., pulmonary nodules ≥6 mm)
研究组 & 干预措施
Usual Care Arm
No Intervention
Unblinded AI-CPA Test Arm
Experimental
干预措施: Heartflow Analysis (Device)
结局指标
主要结局
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
时间窗: Enrollment to 90 days
次要结局
- Time to intensification of LLT(Enrollment through end of study at 21 months)
- % Undergoing lipid testing(Enrollment through end of study at 21 months)
- LDL-C changes(Enrollment through end of study at 21 months)
- Changes in Plaque Volumes(Enrollment through end of study at 21 months)
- Referral to invasive coronary angiography (ICA) and coronary revascularization(Enrollment through end of study at 21 months)
- Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)(Enrollment through end of study at 21 months)
- Percentage of participants who initiate or intensify cardiovascular disease prevention medication therapy(Enrollment through end of study at 21 months)
- Percentage of participants classified as high adherence on the 8-item Morisky Medication Adherence Scale (MMAS-8)(Enrollment through end of study at 21 months)
研究者
研究点 (1)
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