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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Whitney Huey
- 전화번호: 877-478-3569
- 이메일: whuey@heartflow.com
연구 연락처 백업
- 이름: Zachary Sterner, Ph.D
- 전화번호: 877-478-3569
- 이메일: zsterner@heartflow.com
연구 장소
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North Carolina
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Greensboro, North Carolina, 미국, 27401
- REWRITE-CAD Trial Site
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연락하다:
- Heartflow Investigator
- 전화번호: 877-478-3569
- 이메일: rewrite-cad@heartflow.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 유쥬얼케어 암
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실험적: Unblinded AI-CPA Test Arm
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REWRITE-CAD will provide AI-CPA results |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
기간: Enrollment to 90 days
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Enrollment to 90 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
기간: 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 who initiate or intensify cardiovascular disease prevention medication therapy
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
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공동 작업자 및 조사자
스폰서
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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