CaRi-Heart® Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA): A Prospective U.S. Community-Based Study on the Impact of CaRi-Heart® Analysis in Patients Undergoing CCTA for Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15,000
- 试验地点
- 19
- 主要终点
- Change in clinical management decisions following CaRi-Heart® analysis
研究概览
简要总结
This study evaluates the use of CaRi-Heart® analysis, an artificial-intelligence (AI) software tool that measures inflammation in the coronary arteries using images already captured during a standard Coronary CT Angiography (CCTA) exam. The goal is to determine whether the additional information provided by CaRi-Heart® changes clinical decision-making and helps improve early identification and management of coronary artery disease in community imaging centers. Patients who undergo CCTA as part of their regular care will be invited to have their scans analyzed using CaRi-Heart® at no extra cost, time, or radiation.
详细描述
This is a prospective, community-based interventional study designed to assess the incremental value of CaRi-Heart® analysis in patients undergoing Coronary CT Angiography (CCTA) for evaluation of suspected or known coronary artery disease.
CaRi-Heart® is a software-as-a-medical-device (SaMD) that uses advanced AI algorithms to quantify coronary inflammation and generate a CaRi-Heart® Risk Score from existing CCTA images. The analysis provides color-coded visualization and quantitative metrics that may improve risk stratification beyond traditional plaque and stenosis assessment.
The study aims to compare management decisions made before and after review of the CaRi-Heart® analysis, measuring how often the additional information influences diagnostic interpretation or changes treatment recommendations (such as preventive therapy or referral).
Approximately 15,000 participants will be enrolled across multiple outpatient imaging centers in Michigan. All data will be collected under standard clinical workflows with IRB approval, informed consent, and HIPAA compliance. No additional scanning, contrast, or radiation exposure will occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Open-label study. Both investigators and participants are aware of CaRi-Heart® analysis results.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
- •Ability to provide written informed consent
- •Patient between 18 and 80 years old
排除标准
- •History of surgical revascularization (coronary artery bypass graft, CABG)
- •CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR)
- •The CCTA is of poor quality or partly unanalysable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.
- •4. Inability to provide required health information
- •Pregnancy or any known contraindication for CCTA
结局指标
主要结局
Change in clinical management decisions following CaRi-Heart® analysis
时间窗: Up to 60 days following CCTA completion
The proportion of patients for whom the addition of CaRi-Heart® analysis to standard Coronary CT Angiography (CCTA) results in a change in clinical management decisions, such as initiation or adjustment of preventive therapies (e.g., statins, antiplatelet agents, lifestyle modification, or cardiology referral). Management decisions before and after reviewing CaRi-Heart® results will be compared to quantify impact on diagnostic interpretation and treatment planning
次要结局
未报告次要终点