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临床试验/NCT06295861
NCT06295861进行中(未招募)不适用

Prospective Cohort Study of Panvascular Disease

Second Affiliated Hospital, School of Medicine, Zhejiang University2 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2024年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50,000
试验地点
2
主要终点
Cardiovascular adverse events

研究概览

简要总结

To construct a comprehensive big data platform for Chinese people with panvascular disease, and establish a Chinese panvascular disease oriented to guide treatment decisions Cohort and imaging, biological database; According to the clinical features, morphological structure, pathological characteristics of panvascularization, vascular age As the core of the evaluation, a standard evaluation system and a risk prediction model of intervention technology suitable for the diagnosis and treatment of patients with panvascular disease in China were established. Into the Further optimize the treatment strategies, protocols and clinical pathways for panvascular disease to improve patient prognosis and promote its application.

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

入选标准

  • Age ≥18 years old
  • Patients with panvascular disease: i.e., 2 or more of the following vascular diseases.
  • 2.1 Coronary artery: 2.1.1 Coronary atherosclerotic heart disease: including acute coronary syndrome, stable angina, moderate or more stenosis of the coronary artery, history of myocardial infarction, history of coronary revascularization such as stent implantation or bypass grafting.
  • Cerebrovascular: 2.2.1 Intracranial atherosclerotic disease: including ischemic stroke, transient ischemic attack or moderate or more stenosis of the intracranial artery.
  • 2.2.2 Cervical atherosclerotic disease: including carotid artery disease, vertebral artery disease.
  • Aorta: 2.3.1 Aortic atherosclerotic disease: including severe aortic plaque, aortic ulcer, aortic stenosis or atresia, aortic dissection, aortic aneurysm, etc.
  • Peripheral arteries: 2.4.1 Upper limb atherosclerotic disease: including subclavian artery, axillary artery, brachial artery and other sites.
  • Edition 2 January 25, 2024 2.4.2 Renal atherosclerotic disease 2.4.3 Mesenteric atherosclerotic disease 2.4.4 Lower limb atherosclerotic disease
  • Clinical data and biological samples are available
  • The subjects or their legal representatives were informed of the nature of the study and agreed to all terms of participation in the study, and signed the informed consent approved by the ethics committee of each clinical center.

排除标准

  • Currently undergoing treatment for malignant tumor (radiotherapy, chemotherapy, during surgery, etc.)
  • Current medical conditions requiring urgent treatment (this criterion is not excluded after the condition is stabilized): such as acute infection, hypertension crisis, diabetic ketoacidosis, aortic dissection, etc.
  • Current severe heart failure (NYHA class 4)
  • Current liver failure (ALT or AST ≥ 5 times the upper limit of normal) or current renal failure (decreased renal function caused by any reason (defined as eGFR < 30mL/(min·1.73m2))
  • Pregnant or lactating women, or women who plan to become pregnant during the study period
  • Current severe mental illness (except mild to moderate anxiety and depression)
  • Organ transplantation
  • Estimated survival time <3 years
  • Blood-borne infectious diseases: including HIV infection, AIDS, active hepatitis B, hepatitis C, etc.
  • Any condition considered inappropriate for participation in the study by the investigators.

结局指标

主要结局

Cardiovascular adverse events

时间窗: 1, 3, and 5 years follow-up

Cardiovascular mortality

时间窗: 1, 3, and 5 years follow-up

次要结局

  • Rate of receiving vascular revascularization(1, 3, and 5 years follow-up)
  • Readmission rate for vascular reasons(1, 3, and 5 years follow-up)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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