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Japan Central Aortic Pressure Prospective Study (J-CARP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01243840
Recruitment Status : Unknown
Verified June 2010 by Yoshio Matsui, Jichi Medical University.
Recruitment status was:  Recruiting
First Posted : November 19, 2010
Last Update Posted : January 25, 2012
Information provided by (Responsible Party):
Yoshio Matsui, Jichi Medical University

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.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Central Blood Pressure Follow-up Study in Japanese
Study Start Date : June 2010
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2019

Primary Outcome Measures :
  1. •Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. New onset of hypertension, diabetes mellitus, or atrial fibrillation [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01243840

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Iwakuni City Medical Center Recruiting
Iwakuni, Yamaguchi, Japan, 740-0021
Contact: Yoshio Matsui    +81-827-21-3211   
Principal Investigator: Yoshio Matsui, MD         
Sponsors and Collaborators
Yoshio Matsui
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Study Director: Kazuomi Kario, MD Jichi Medical University School of Medicine
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Responsible Party: Yoshio Matsui, Sponsor-Investigator, Jichi Medical University Identifier: NCT01243840    
Other Study ID Numbers: J-CARP
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: June 2010
Keywords provided by Yoshio Matsui, Jichi Medical University:
Central aortic pressure
Aortic pulse wave velocity
Aortic PWV using a single pressure recording
Vascular aging
Left ventricular hypertrophy
Left ventricular diastolic function