Artificial Intelligence-assisted CT for Risk Stratification in COronary Artery Disease to PreveNt Future Coronary Events and Improve Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
研究概览
简要总结
The goal of this observational study is to learn if AI-assisted cardiac CT imaging can improve cardiovascular risk stratification and prediction of future coronary events in an adult population undergoing clinically indicated cardiac CT.
The main questions it aims to answer are:
- Can AI-enhanced cardiac CT accurately assess cardiovascular risk in a real-world adult population?
- How do CT-derived plaque characteristics correlate with clinical, biochemical, and lifestyle risk factors? Researchers will compare subgroups (e.g., patients with different risk profiles, biomarkers, or imaging findings, and a subset undergoing OCT imaging) to see if differences in imaging and clinical parameters are associated with cardiovascular risk and plaque vulnerability.
Participants will:
- Provide informed consent and medical history/demographic information
- Undergo blood sampling for cardiovascular and metabolic biomarkers
- Have a resting ECG performed
- Complete a detailed lifestyle and health questionnaire
- Receive a non-invasive cardiac CT scan interpreted by an expert
- Potentially receive heart rate-lowering medication (e.g., metoprolol) if required for imaging quality
- Be referred for further clinical evaluation if clinically indicated 
详细描述
The ACTION Registry (Artificial Intelligence-assisted CT for Risk Stratification in Coronary Artery Disease) is a prospective, single-centre, observational patient registry conducted at the Clinical Research Facility, University Hospital Galway.
This registry is designed to systematically collect and integrate multimodal data from adults undergoing clinically indicated cardiac computed tomography (CT) to support advanced cardiovascular risk assessment using artificial intelligence (AI)-based approaches.
Registry Design and Procedures Eligible participants are consecutively enrolled at the time of referral for clinically indicated cardiac CT. Following informed consent, data are collected during a single baseline visit and supplemented by routine clinical data and follow-up information where available.
Registry procedures include:
- Collection of demographic and clinical data from medical records
- Blood sampling for cardiovascular and metabolic biomarkers
- Resting electrocardiogram (ECG)
- Structured questionnaires capturing lifestyle, cardiovascular history, and risk factors
- Standard-of-care cardiac CT imaging acquisition and expert interpretation
- Recording of medication use and clinically relevant interventions A subset of participants undergoing invasive imaging (e.g., optical coherence tomography) will have additional data collected for cross-modality comparison.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥18 years
- •Undergoing clinically indicated cardiac CT
- •Able and willing to provide informed consent
排除标准
- •History of malignancy
- •Abnormal renal function (e.g., eGFR or serum creatinine outside reference range)
- •Contraindications to iodinated contrast agents or CT imaging
研究者
Faisal Sharif
Professor
University of Galway