NCT01243840Unknown不适用
Central Blood Pressure Follow-up Study in Japanese
Yoshio Matsui1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2010年6月最近更新:
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
- •Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure
研究概览
简要总结
Purpose of the study
- The predictive value of central aortic pressure and aortic pulse wave velocity (PWV) in a Japanese population is not known. The purpose of this study is to quantify the predictive value of these indices in the determination of cardiovascular risk.
- Recently, a non-invasive method to separate the aortic pressure waveform into the separate ejection pressure wave and reflected pressure wave has become available. With this decomposition method, it is possible to estimate aortic PWV (named AVI). The second objective of this study is to determine if AVI can be a substitute for carotid-femoral PWV (cf-PWV), the current gold standard for aortic PWV measurement.
- To study vascular aging of the Japanese population by evaluating central blood pressure and aortic PWV by age, and compare these values to similar studies done in Caucasian and Chinese patient populations.
- To study the relationship between the magnitude of the aortic reflected pressure wave and the degree of left ventricular (LV) hypertrophy and LV diastolic function.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who visit hospital for their health checks
- •Healthy volunteers who agree to participate in this study
排除标准
- •History of coronary artery disease, cerebrovascular disease, congestive heart failure, aortic dissection
- •Subjects taking vasoactive drugs (antihypertensive and/or nitrates)
- •Atrial fibrillation or atrial flutter
- •Renal dysfunction (serum creatinine ≥3 mg/dl)
- •Type I diabetes mellitus
- •Hepatic dysfunction (AST and/or ALT ≥100 IU/l)
- •A history of malignant tumor within 5 years of enrollment or suspected
- •Pregnancy, possible pregnancy
- •Chronic inflammation disease
- •Not suited to the clinical trial as judged by a collaborating physician
- •Inability to give informed consent
结局指标
主要结局
•Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure
时间窗: 5 years
次要结局
- New onset of hypertension, diabetes mellitus, or atrial fibrillation(5 years)
研究者
Yoshio Matsui
Sponsor-Investigator
Jichi Medical University
研究点 (1)
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