NCT06016608招募中不适用
Early Screen, Systematic Evaluation and Risk Warning of Polyvascular Disease Based on Multi-modality Imaging
Harbin Medical University1 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2023年10月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Task1: MACE
研究概览
简要总结
- Establish a multimodality imaging database for PVD, improve the one-stop screening process for early PVD based on artificial intelligence, build a full-cycle control information platform, and promote the construction and standardization of a multidisciplinary co-morbidity and co-management diagnosis and treatment model.
- Based on non-invasive, zero-contrast ocular OCTA combined with one-stop CTA imaging of the heart and brain, construct an integrated "eye-heart-brain" early warning model for PVD, and explore a potential non-invasive and convenient early warning system for PVD.
- Based on the multi-omics, investigate EVs-mediated intercellular communication network, elucidate the roles and regulatory mechanisms of EVs in the development of PVD, search for potential targets for intervention, and construct an artificial intelligence-based "pan-vascular score" risk assessment system based on the combination of multi-modality imaging and multi-omics biomarkers.
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
- 否
入选标准
- •Patients with coronary artery disease (≥50% stenosis in any coronary artery on coronary angiography)
- •Age ≥18 years old
- •Proposed OCT-IVUS integrated imaging system
- •able to provide written informed consent prior to the start of any procedures related to the study.
- •patients with coronary artery disease (coronary angiography reveals ≥50% degree of stenosis in any coronary artery) and patients with stroke or TIA (confirmed by a neurologist)
- •Age ≥ 18 years
- •able to provide written informed consent prior to the start of any procedures related to the study.
排除标准
- •severely tortuous/calcified coronary arteries with anticipated difficulty in completing the OCT-IVUS integrated imaging system
- •uncontrolled congestive heart failure or acute left heart failure;plan
- •claustrophobia;
- •left main stem occlusion;
- •proposed coronary artery bypass grafting (CABG);
- •uncontrolled severe ventricular arrhythmia;
- •active bleeding or severe bleeding tendency;
- •acute stroke;
- •patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;
- •severe renal insufficiency and/or anuria, except in cases where dialysis treatment has been planned;
- •contraindications to the application of contrast media;
- •patients who are severely uncooperative due to psychiatric or serious systemic illness;
- •Patients who, in the opinion of the investigator, are unsuitable for participation in the study.
- •patients who are unable to comply with the follow-up schedule;
- •uncontrolled congestive heart failure or acute left heart failure;
- •patients with a life expectancy of less than 6 months;
- •left main stem occlusion;
- •proposed coronary artery bypass grafting (CABG);
- •uncontrolled severe ventricular arrhythmia;
- •active bleeding or severe bleeding tendency;
- •patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;
- •severe renal insufficiency and/or anuria, except in cases where dialysis treatment has been planned;
- •contraindications to the application of contrast media;
- •patients who are severely uncooperative due to psychiatric or serious systemic illness;
- •patients who, in the opinion of the investigator, are not suitable for participation in the study.
结局指标
主要结局
Task1: MACE
时间窗: 1 year
All cause death, stroke, myocardial reinfarction, unplanned revascularization, lower extremity artery disease
Task2: Plaque characteristics
时间窗: 1 year
Plaque morphology on OCT
次要结局
未报告次要终点
研究者
Yu Bo
Director
Harbin Medical University
研究点 (1)
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