Japan Central Aortic Pressure Prospective Study

NCT ID: NCT01243840

Last Updated: 2012-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2019-06-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yoshio Matsui

OTHER

Sponsor Role lead

Responsible Party

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Yoshio Matsui

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kazuomi Kario, MD

Role: STUDY_DIRECTOR

Jichi Medical University School of Medicine

Locations

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Iwakuni City Medical Center

Iwakuni, Yamaguchi, Japan

Site Status RECRUITING

Countries

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Japan

Facility Contacts

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Yoshio Matsui

Role: primary

+81-827-21-3211

Other Identifiers

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J-CARP

Identifier Type: -

Identifier Source: org_study_id

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