건강 강화 동맥 위험 추적 및 ASCVD에서의 광범위한 시행 및 선별 노력 (HEARTWISE-ASCVD) (HEARTWISE)
Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in AtheroSclerotic CardioVascular Disease (HEARTWISE-ASCVD) Study
This multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults. The study uses artificial intelligence to detect calcium buildup in heart arteries (coronary artery calcium or CAC) on chest CT scans that patients have already had for other reasons. The study will focus on adults who either have known atherosclerotic cardiovascular disease (ASCVD) or have significant calcium buildup (a CAC score of 100 or higher), and whose cholesterol is not well controlled.
It will also evaluate how well this approach can be implemented at scale across multiple health systems. The main questions it aims to answer are:
Does notifying patients and their clinicians about incidental CAC increase lipid-lowering therapy(LLT) initiation or intensification?
Does the intervention improve Low-Density Lipoprotein(LDL)-cholesterol control and related lipid testing?
How does the intervention affect downstream care (e.g., clinic visits, cardiology referrals, and cardiac testing)?
Researchers will use an FDA-cleared AI algorithm to quantify CAC on previously performed non-gated chest CT scans and identify eligible participants through the electronic health record. Participants will be randomized to receive CAC notification either right away or after a 6-month delay.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
California
-
Los Angeles, California, 미국, 90095
- University of California, Los Angeles
-
Pleasanton, California, 미국, 94588
- Kaiser Permanente Northern California
-
Stanford, California, 미국, 94305
- Stanford University
-
-
North Carolina
-
Durham, North Carolina, 미국, 27710
- Duke University Medical Center
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37232
- Vanderbilt University Medical Center
-
-
Texas
-
Dallas, Texas, 미국, 95226
- Baylor Scott & White
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
Non-gated chest CT performed within the prior 2 years within the health system
-
Active health system engagement with an affiliated clinician eligible for notification, defined as ≥1 clinical visit within the prior 2 years AND at least one of the following:
- Active enrollment in the site's integrated healthcare plan (e.g., Kaiser Permanente Northern California), OR
- LDL-C measured within the health system within the prior 2 years, OR
- Outpatient cardiovascular medication prescription within the prior year
-
Meets one of the following clinical criteria:
- Clinical ASCVD diagnosis (coronary artery disease, peripheral arterial disease, or ischemic cerebrovascular disease) AND AI-detected CAC >0 on non-gated chest CT, OR
- No ASCVD diagnosis AND AI-detected CAC ≥100
-
Suboptimal LDL-C control, defined as either: Last LDL-C ≥70 mg/dL in the last 2 years, OR No LDL-C measurement in the last 2 years
Note: Site-level variations and additional refinements may occur based on local stakeholder input and patient population identification.
Exclusion Criteria:
- Dementia
- Heart transplant
- Active hospice
- Other life-limiting illness as determined by the site investigator (e.g., metastatic cancer)
- Additional participant-level exclusions as determined by clinical stakeholders at each site
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Early Notification
For participants randomized to notification, the affiliated clinician will receive a message notifying them of the presence of CAC. The notification will include a description of the significance of CAC, provide guideline recommendations, and include a personalized CAC image (as possible). The message will recommend having a risk discussion with the participant. Based on site-level stakeholder feedback, this alert can be retriggered at 2 months for participants who do not have LLT initiation or intensification or LDL-C testing. Participants will also receive a notification. Based on stakeholder input, this notification can be delivered centrally or from individual clinicians. The notification will include a description of the significance of CAC, a personalized image (as possible), and recommend a risk discussion with their clinician. |
After randomization to the early notification arm, the study team will send a standardized notification message to the participant's affiliated clinician. The study team will send a message to the participant after a brief delay. Each site will determine the timing between the initial message to the clinician and the participant based on stakeholder feedback. The notification is about the AI-CAC identified on the participant's previous chest CT. It will provide an overview of AI-CAC, a personalized image of AI-CAC, and a recommended risk discussion with their clinician. These clinicians will also be notified of the findings. For participants randomized to early notification who do not undergo LLT initiation, intensification, or LDL testing within 2 months, the clinician and participant will receive a second message at that time. The participants in the delayed notification arm will receive a similar notification 6 months later. |
|
간섭 없음: Delayed Notification
Participants will have their CT scans interpreted and reported according to standard clinical practice. This may mention the presence of CAC in the official radiology imaging report, per usual practice. Participants will not receive any notification beyond this standard of care during the 6-month study period. The study team will send a similar notification as the early notification arm to the participants after completion of the study's primary endpoint assessment. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Lipid-lowering therapy initiation or intensification (LLTI)
기간: 6 months after participant randomization
|
|
6 months after participant randomization
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Aspirin prescription
기간: 6 months after participant randomization
|
Number of new Aspirin or other antiplatelet prescription |
6 months after participant randomization
|
|
Lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides) ordering
기간: 6 months after participant randomization
|
Number of Lipid panel ordering |
6 months after participant randomization
|
|
Lipoprotein(a) test ordering
기간: 6 months after participant randomization
|
Number of Lipoprotein(a) test ordering |
6 months after participant randomization
|
|
Changes of total cholesterol, HDL-C, LDL-C, triglycerides, Lipoprotein(a) levels
기간: 6 months after participant randomization
|
This outcome measure the changes of the test levels |
6 months after participant randomization
|
|
Healthcare resource use
기간: Baseline through Month 6
|
|
Baseline through Month 6
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Fatima Rodriguez, MD, MPH, Stanford University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 84062
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .