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临床试验/NCT03616418
NCT03616418已完成不适用

Ankle Brachial Index Combined With Serum Uric Acid Levels Improve Prediction All Cause Mortality and Cardiovascular Mortality in the Elderly Chinese Population

Shanghai 10th People's Hospital0 个研究点目标入组 3,026 人开始时间: 2017年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,026
主要终点
all cause mortality and cardiovascular mortality

研究概览

简要总结

Peripheral arterial disease (PAD) is a common clinical manifestation of the systemic atherosclerotic process, and the ankle brachial index (ABI) is an ideal tool to diagnose PAD. The association between high serum uric acid levels (SUA) and arterial stiffness as well as endothelial dysfunction has been demonstrated in humans and uric acid has been suggested to be an important modulator of the inflammatory process. It has also been confirmed by clinical studies. Currently, there have been few long term follow up studies focused on the whether serum uric acid levels combined with ankle brachial index can improve prediction all cause mortality and cardiovascular mortality,especially in China population.Therefore, the aim of this study was to elucidate whether ABIcombined with SUA can improve prediction all cause mortality and cardiovascular mortality in the elderly China population independently of the traditional Framingham Risk Score.

详细描述

This study is a prospective community-based cohort study, which is aimed to investigate the prognostic factors, including conventional cardiovascular risk factors and measure ABI,SUA,asymptomatic target organ damage, for mortality and cardiovascular diseases. All population were separated into ABI ≤0.50,0.51 <ABI ≤0.9,and 0.91 <ABI≤1.40 three groups according to the ABI. ABI ≤0.9 was selected as cut point for the definition of PAD. Factors related to CVD and all-cause mortality, major adverse cardiac events (MACE) during follow-up was observed by multivariate Cox regression analysis and log rank test. Potential confounding variables with P <0.10 were adjusted for multivariate analysis.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • age≥65 years old
  • Shanghai residents
  • Sign informed consent

排除标准

  • serious heart disease (NYHA>IV) or end stage renal disease (CKD > 4)
  • cancer and life expectancy was less than 5 years
  • Severe congestive heart failure and Severe renal failure patients
  • Participants had other diseases that required withdrawal from the clinical trial
  • Patients are reluctant to participate in clinical research
  • The patient violated the experimental protocol
  • Clinical diagnosis of Alzheimer's Disease

结局指标

主要结局

all cause mortality and cardiovascular mortality

时间窗: From August 2018 to August 2020

Cardiovascular events definitions: Hospitalized myocardial infarction was classified as definite or probable based on chest pain symptoms, cardiac enzyme levels, and electrocardiographic findings, or angioplasty28. Coronary heart disease was determined to be present if there was (1) electrocardiographic (ECG) evidence of a prior myocardial infarction, (2) prior coronary artery bypass surgery or angioplasty, (3) Coronary angiography show coronary heart disease, (4) have symptoms of angina and ECG revealed myocardial ischemia performance or laboratory tests showed cardiac enzymes increased and exclude other types of disease, (5) a self-reported history of a physician-diagnosed heart attack 29. CHD death was classified "definite" based on chest pain symptoms, hospital records, and medical history.

次要结局

未报告次要终点

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ya-Wei Xu

cardiology department of shanghai 10th people's hospital

Shanghai 10th People's Hospital

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