REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease (REWRITE-CAD)
Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Whitney Huey
- 電話番号：877-478-3569
- メール：whuey@heartflow.com
研究連絡先のバックアップ
- 名前：Zachary Sterner, Ph.D
- 電話番号：877-478-3569
- メール：zsterner@heartflow.com
研究場所
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North Carolina
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Greensboro、North Carolina、アメリカ、27401
- REWRITE-CAD Trial Site
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コンタクト：
- Heartflow Investigator
- 電話番号：877-478-3569
- メール：rewrite-cad@heartflow.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
Non-imaging based
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Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)
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On PCSK9i and/or inclisiran at baseline
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Reduced left ventricular ejection fraction (LVEF) <35%, if known
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Prior coronary artery bypass graft (CABG)
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Prior stents in 2+ vessel territories
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Life expectancy less than 2 years due to non-CV comorbidities
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Enrolled in an investigational trial that involves a non-approved cardiac drug or device
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Previously evaluated with and/or in a trial which includes AI-CPA
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Any condition that might interfere with trial procedures or follow up visits
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LDL-C <70 mg/dL at baseline lab draw
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Active chemotherapy and/or radiation
Imaging Based (all to be assessed by CCTA core lab)
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Left Main (LM) ≥50% stenosis on baseline CCTA
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Proximal LAD FFRct <0.75
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Total occlusions in major vessels and/or total occlusion in stent
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No visible plaque in non-stented segments on CCTA
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Incidental findings requiring immediate follow-up or management (e.g., Aortic dissection, findings suggestive of cancer, pulmonary embolism)
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Findings that require further imaging follow-up within 1 year (e.g., pulmonary nodules ≥6 mm)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：いつものケアアーム
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実験的：Unblinded AI-CPA Test Arm
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REWRITE-CAD will provide AI-CPA results |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
時間枠：Enrollment to 90 days
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Enrollment to 90 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
時間枠：Enrollment through end of study at 21 months
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Enrollment through end of study at 21 months
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|
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Percentage of participants who initiate or intensify cardiovascular disease prevention medication therapy
時間枠：Enrollment through end of study at 21 months
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Enrollment through end of study at 21 months
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Time to intensification of LLT
時間枠：Enrollment through end of study at 21 months
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Enrollment through end of study at 21 months
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|
% Undergoing lipid testing
時間枠：Enrollment through end of study at 21 months
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Enrollment through end of study at 21 months
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LDL-C changes
時間枠：Enrollment through end of study at 21 months
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Enrollment through end of study at 21 months
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Changes in Plaque Volumes
時間枠：Enrollment through end of study at 21 months
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Enrollment through end of study at 21 months
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Referral to invasive coronary angiography (ICA) and coronary revascularization
時間枠：Enrollment through end of study at 21 months
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Enrollment through end of study at 21 months
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Percentage of participants classified as high adherence on the 8-item Morisky Medication Adherence Scale (MMAS-8)
時間枠：Enrollment through end of study at 21 months
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Evaluated using the 8-item MMAS-8 questionnaire. Total scores range from 0 to 8, where higher scores indicate better adherence. High adherence is defined as achieving a score of 8, medium adherence as 6 to <8, and low adherence as <6. |
Enrollment through end of study at 21 months
|
協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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