Japan Central Aortic Pressure Prospective Study

Healthy Clinical Trial

— J-CARP  

Official title:

Central Blood Pressure Follow-up Study in Japanese

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01243840
• Other study ID #: J-CARP
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2010
• Last updated: January 23, 2012
• Start date: June 2010
• Est. completion date: June 2019

Study information

• Verified date: June 2010
• Source: Jichi Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 2019
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Japan	Iwakuni City Medical Center	Iwakuni	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
Yoshio Matsui

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	•Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure		5 years	Yes
Secondary	New onset of hypertension, diabetes mellitus, or atrial fibrillation		5 years	Yes