Rustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 2
- 主要终点
- Quantitative assessment of the atherosclerotic burden and high risk plaque features
研究概览
简要总结
Coronary artery disease (CAD) is among the leading cause of death and disability. Identification of patients at high risk of cardiovascular events is pivotal. However, current risk stratification based on imaging and known biomarkers is suboptimal. The objective of this proposal is to develop a multicriteria decision model for non-invasive assessment of vulnerable atherosclerotic patients and to evaluate its ability to predict the occurrence of an adverse event in intermediate-to-high risk patients with suspected or known CAD. The planned workflow includes a first step using a retrospective cohort of patients undergoing clinically indicated coronary angiography (CCTA) to develop an integrated application for automatic coronary artery segmentation, quantitative plaque analysis, biomechanics and fluid dynamics, based on machine learning, radiomics and computational analysis approaches and validated against the reference standard for each tool. The second step will apply this new methodology to a larger retrospective cohort of patients with the integration of genomic biomarker assessment to derive the most accurate risk stratification model to properly identify vulnerable patients and vulnerable plaques with respect to outcome. Finally, in the third step, the derived predictive model will be prospectively validated in an independent cohort of patients from an ongoing study (CTP-PRO study) to assess the robustness and accuracy of the proposed solution.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation;
- •CCTA performed with state-of-the-art scanner technology, i.e., scanners with more than 64 slices.
排除标准
- •performance of any non-invasive diagnostic test within 90 days before enrolment;
- •low-to-intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score;
- •acute coronary syndrome;
- •evidence of clinical instability;
- •contraindication to contrast agent administration and/or impaired renal function;
- •inability to sustain a breath hold;
- •pregnancy;
- •cardiac arrhythmias;- presence of a pacemaker or implantable cardioverter defibrillator;
- •contraindications to the administration of sublingual nitrates, β-blockers or adenosine;
- •structural cardiomyopathy
结局指标
主要结局
Quantitative assessment of the atherosclerotic burden and high risk plaque features
时间窗: January 2026
* Extent and severity of coronary atherosclerosis (Leaman Score, number of lesions); * Vulnerability indices: plaque burden (total plaque volume, plaque density), LAP, PR, NRS and SC; * Fluid dynamic indexes of the coronary artery such as the CT derived Fractional Flow Reserve
Creation of an automated integrative artificial intelligence (AI) approach for the stratification of CAD patients and assessment of vulnerable coronary plaques at risk of acute complications
时间窗: January 2026
The main aim of the project develop a multicriteria decision model for the automatic (AI-assisted) non-invasive assessment of vulnerable atherosclerotic patients and evaluate the ability of this model to predict the occurrence of adverse event in intermediate-to-high risk patients with suspected or known CAD. As adverse events, we will consider the annual rate of events, intended as death or hospitalization for revascularization (either CABG or PCI)
次要结局
未报告次要终点
