Japan Central Aortic Pressure Prospective Study

• Conditions: Healthy

• Registration Number: NCT01243840
• Lead Sponsor: Yoshio Matsui

Brief Summary

Purpose of the study

1. 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.

2. 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.

3. 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.

4. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-06
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Last Update Submitted: 2012-01-23
• Last Update Posted: 2012-01-25
• Primary Completion: 2014-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Subjects who visit hospital for their health checks
• Healthy volunteers who agree to participate in this study

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure	5 years

Secondary Outcome Measures

Name	Time	Method
New onset of hypertension, diabetes mellitus, or atrial fibrillation	5 years

Trial Locations

Locations (1)

Iwakuni City Medical Center; 🇯🇵 Iwakuni, Yamaguchi, Japan