Clinical trial NCT01243840: Japan Central Aortic Pressure Prospective Study
Official title: Central Blood Pressure Follow-up Study in Japanese
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Jichi Medical University
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ages eligible for Study: 20 Years to 90 Years Genders eligible for Study: Both Accepts healthy volunteers: Yes

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.


Eligibility criteria: 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

Primary outcomes:
measure: •Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure
timeFrame: 5 years
Secondary outcomes:
measure: New onset of hypertension, diabetes mellitus, or atrial fibrillation
timeFrame: 5 years
Other outcomes:
Locations:
city: Iwakuni
country: Japan
facility: Iwakuni City Medical Center
state: Yamaguchi
Study officials:
affiliation: Jichi Medical University School of Medicine
name: Kazuomi Kario, MD
role: STUDY_DIRECTOR
References: