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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01243840
Recruitment Status : Recruiting
First Posted : November 19, 2010
Last Update Posted : January 25, 2012
Information provided by (Responsible Party):
Yoshio Matsui, Jichi Medical University

November 18, 2010
November 19, 2010
January 25, 2012
June 2010
June 2014   (Final data collection date for primary outcome measure)
•Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01243840 on Archive Site
New onset of hypertension, diabetes mellitus, or atrial fibrillation [ Time Frame: 5 years ]
Same as current
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Japan Central Aortic Pressure Prospective Study
Central Blood Pressure Follow-up Study in Japanese

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.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Ages eligible for Study: 20 Years to 90 Years Genders eligible for Study: Both Accepts healthy volunteers: Yes
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2019
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 90 Years   (Adult, Senior)
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Yoshio Matsui, Jichi Medical University
Yoshio Matsui
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Study Director: Kazuomi Kario, MD Jichi Medical University School of Medicine
Jichi Medical University
June 2010