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临床试验/NCT03154203
NCT03154203Unknown不适用

The Study of Non-Invasive Aortic Ambulatory Blood Pressure Monitoring for The Detection of Target Organ Damage in The Population Of Chinese Patient (SAFAR-China)

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
试验地点
1
主要终点
Cardiovascular events

研究概览

简要总结

This study is a sub-investigation of SAFAR study. Consecutive patients with established hypertension (treated or untreated with antihypertensive drugs) or with suspected hypertension are recruited and their 24-hour brachial and aortic blood pressures, cardiovascular risk factors and target organ damage are assessed. And the participants' target organ damage, cardiovascular events, cardiovascular and overall mortality will be followed four years later.

详细描述

SAFAR study is an ongoing perspective study which is performed in Greek. We have been participated this study and now we are going to expand this study in Chinese population.

In Shanghai Tenth People's Hospital, we recruit consecutive patients who meet the including criteria. And their medical and family history are obtained with standardized structured questionnaire including information about smoking and drinking and exercise habits, history of diabetes mellitus, cardio-cerebrovascular disease, renal disease and peripheral arterial disease, use of antihypertensive, lipid-regulating and hypoglycemic drugs. Their biochemical examinations of venous blood and urine were measured after an overnight fast.

For the 24-hour brachial and aortic ambulatory blood pressure monitoring of each patient, we use the Mobil-O-Graph NG apparatus (IEM, Stolberg, Germany), which is well validated and now commercially available.

All participants underwent carotid and cardiac ultrasonography by a validated ultrasound system (Mylab 30 CV machine, ESAOTE SPA, Genoa, Italy). The parameters of cardiac function and structure and the parameters of carotid arteries are assessed according to the ASE recommendation. Further, we use these parameters to estimate the damage of heart and carotid artery including left ventricular mass index (LVMI), carotid left ventricular diastolic function (LVDD), intima-media thickness (CIMT) and cross-sectional area(CCSA).

Four years later, the above measurements will be performed again and the corresponding data of events and mortality will be collected.

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

  • patients with established hypertension (treated or untreated with antihypertensive drugs) or with suspected hypertension

排除标准

  • Age<18 years old
  • the absence of sinus rhythm during BP monitoring
  • any modification in cardiovascular disease medication in the past month
  • inability to provide informed consent or unwillingness/inability to adhere to study protocol

结局指标

主要结局

Cardiovascular events

时间窗: 4 years

cardiovascular and all-cause mortality

时间窗: 4 years

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

Director of Department of Cardiology, Professor of Tongji University, FACC

Shanghai 10th People's Hospital

研究点 (1)

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