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临床试验/NCT02569268
NCT02569268已完成不适用

Early Vascular Disease Detection System for High Risk Patients in Beijing

Peking University Shougang Hospital0 个研究点目标入组 2,000 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,000
主要终点
Number of vascular diseases-related death

研究概览

简要总结

Arteriosclerotic vascular-related diseases have become a serious threat to human health. The prevention and reversal of vascular events has become an important direction of medicine. Early vascular disease detection system includes pulse wave velocity (PWV), carotid intima-media thickness (IMT) and coronary flow velocity reserve (CFVR), flow-mediated vasodilation (FMD), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), insulin resistance index (HOMA-IR), hypersensitivity C- reactive protein (hs-CRP), plasma homocysteine (Hcy), B-type natriuretic peptide (BNP), uric acid (UA), and so on. However, there is no international and domestic comprehensive study on simple and practical evaluation system by jointing application of these evaluation indexes to detect vascular disease. Combined evaluation function can simultaneously detect and evaluate vascular abnormalities, make up a single indicator shortcoming in clinical applications from multiple levels of vascular structure and function. However, all indicators testing not only cause time consuming, but also increase the burden on patients, resulting unnecessary waste of medical resources. Thus, the present study was to select appropriate indicators and effective joint, and establish the rating system, using the vascular system to predict the incidence of terminal events, and compare this system with the previous scoring system such as FRS (Framingham Risk Score) pros and cons.

详细描述

This study aimed to establish vascular disease early detection system and scoring systems by comprehensive vascular disease risk factors and vascular function evaluation index. And prevention of vascular-related diseases, high-risk groups through positive lifestyle changes: such as lipid-lowering, smoking cessation, reversing early vascular lesions, to avoid end-stage vascular events.

  1. Detection of vascular function indicators include: PWV, IMT, CFVR, FMD, CAVI, ABI, LDL-C, HOMA-IR, hs-CRP, Hcy, BNP, UA and so on.
  2. Design the questionnaire: surveying the lifestyle, personal history, family history of the study population.
  3. Follow-up:2 years of observation, recording the end time of vascular events, including cardiovascular events (acute myocardial infarction, angina, coronary reperfusion therapy), stroke, heart failure, peripheral vascular disease.
  4. Statistics: Complex the factors of vascular disease, screen for an effective indicator to predict cardiovascular events, and based on the weight of the different factors, the establish the rating system, use the system to predict the incidence of vascular events terminal, and compare the system with the previous scoring system such as FRS (Framingham Risk Score).

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
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • health subjects with or without history of vascular-related diseases; or
  • hypertension subjects; or
  • diabetes mellitus subjects; or
  • coronary artery disease; or
  • cerebrovascular disease;or
  • hyperlipidemia subjects.

排除标准

  • severe infectious diseases and inflammatory diseases;
  • liver and kidney failure;
  • immunological diseases;
  • hematological system diseases。

结局指标

主要结局

Number of vascular diseases-related death

时间窗: Up to 1 year

次要结局

  • Number of acute heart failure(Up to 1 year)
  • Number of acute coronary syndrome(Up to 1 year)
  • Number of peripheral arteriosclerosis occlusion(Up to 1 year)
  • Number of acute stroke(Up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongyu Wang

Director and Professor of Vascular Medicine

Peking University Shougang Hospital

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