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临床试验/NCT04811547
NCT04811547已完成不适用

Adding Ankle Brachial Index to Traditional Framingham Risks Can Improve All-cause Mortality and Cardiac Mortality Prediction in Medium and High Framingham Risk Score Patients: A China Prediction Model

Shanghai 10th People's Hospital0 个研究点目标入组 3,687 人开始时间: 2011年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,687
主要终点
All-Causes mortality and Cardiac mortality

研究概览

简要总结

Framingham Risk Score (FRS) included age, gender, body mass index (BMI), cigarette smoking, blood pressure, total cholesterol (TC), LDL-cholesterol (LDL-C) and diabetes mellitus (DM). Previously, Framingham cohort study and other study has confered patients with medium or high FRS had worse prognosis. However, the score list was tending to over-estimate risk in medium FRS or under-estimate risk in high FRS patients . For this reason, ACC/AHA cholesterol guidelines also recommend the use of additional markers to improve atherosclerotic cardiovascular disease (ASCVD) risk assessment and medical decision making.

Meanwhile, the ABI, which was the ratio of systolic pressure at the ankle to that in the arm, was quick, easy and used to diagnosis and assess the severity of peripheral artery disease (PAD) in the legs. Several research have shown its low value as an indicator of general atherosclerosis and independently risk associated with cardiovascular events in prospective studies . In addition, ABI aggressively modified risk factors and accelerated the adverse prognosis of ASCVD. However, whether FRS or ABI, were all related to participants and race. And, most studies were from western countries, lack of Asian date, especially aimed at risk prediction model research. Therefore, this research was aimed to validate incorporating ABI and relevant Framingham risk variables whether could improve prediction all-cause mortality and cardiac mortality in medium and high Framingham risk score (FRS) patients.

详细描述

The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011.

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

  • 未提供

排除标准

  • •Patients were suffering from mental illness.
  • •Life expectancy of patients were less than 1 year.

结局指标

主要结局

All-Causes mortality and Cardiac mortality

时间窗: from November 2011 to June 2018

In this study, the Cardiac death was only cardiac event death. Medical records and death certificates of all patients who had an event were obtained and validated by cardiologist. Death was confirmed from hospital records or by contact with participants and their families. All materials were reviewed independently by five senior physicians of the cohort study to confirm the cause of death.

次要结局

  • New-onset Cardiovascular Events(from November 2011 to June 2018)

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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