Japan Central Aortic Pressure Prospective Study

Central Blood Pressure Follow-up Study in Japanese

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01243840

Acronym

J-CARP

Enrollment

3000

Registered

2010-11-19

Start date

2010-06-30

Completion date

2019-06-30

Last updated

2012-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Central aortic pressure, Aortic pulse wave velocity, Aortic PWV using a single pressure recording, Vascular aging, Left ventricular hypertrophy, Left ventricular diastolic function

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
New onset of hypertension, diabetes mellitus, or atrial fibrillation	5 years

Countries

Japan

Outcome results