Japan Central Aortic Pressure Prospective Study (J-CARP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by Jichi Medical University
Sponsor:
Information provided by (Responsible Party):
Yoshio Matsui, Jichi Medical University
ClinicalTrials.gov Identifier:
NCT01243840
First received: November 18, 2010
Last updated: January 23, 2012
Last verified: June 2010

November 18, 2010
January 23, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01243840 on ClinicalTrials.gov Archive Site
New onset of hypertension, diabetes mellitus, or atrial fibrillation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
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
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

Healthy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
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
Both
20 Years to 90 Years
Yes
Japan
 
NCT01243840
J-CARP
No
Yoshio Matsui, Jichi Medical University
Yoshio Matsui
Not Provided
Study Director: Kazuomi Kario, MD Jichi Medical University School of Medicine
Jichi Medical University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP