Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in AtheroSclerotic CardioVascular Disease (HEARTWISE-ASCVD) Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120,000
- 试验地点
- 6
- 主要终点
- Lipid-lowering therapy initiation or intensification (LLTI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: AI-Detected CAC Notification and Care Facilitation (Other)
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.
结局指标
主要结局
Lipid-lowering therapy initiation or intensification (LLTI)
时间窗: 6 months after participant randomization
* Number of new statin prescriptions * Number of statin doses/intensity increase * Number of PSCK9 inhibitor initiation (monoclonal antibodies and siRNA) * Number of Ezetimibe initiations * Number of Bempedoic acid initiations
次要结局
- Aspirin prescription(6 months after participant randomization)
- Lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides) ordering(6 months after participant randomization)
- Lipoprotein(a) test ordering(6 months after participant randomization)
- Changes of total cholesterol, HDL-C, LDL-C, triglycerides, Lipoprotein(a) levels(6 months after participant randomization)
- Healthcare resource use(Baseline through Month 6)
研究者
Fatima Rodriguez
Associate Professor of Medicine (Cardiovascular Medicine)
Stanford University