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Japan Central Aortic Pressure Prospective Study (J-CARP)

This study is currently recruiting participants.
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
History of Changes
  Purpose

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
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Central Blood Pressure Follow-up Study in Japanese

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jichi Medical University:

Primary Outcome Measures:
  • •Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • New onset of hypertension, diabetes mellitus, or atrial fibrillation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: June 2010
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243840

Locations
Japan
Iwakuni City Medical Center Recruiting
Iwakuni, Yamaguchi, Japan, 740-0021
Contact: Yoshio Matsui     +81-827-21-3211     yoshio@jichi.ac.jp    
Principal Investigator: Yoshio Matsui, MD            
Sponsors and Collaborators
Yoshio Matsui
Investigators
Study Director: Kazuomi Kario, MD Jichi Medical University School of Medicine
  More Information

No publications provided

Responsible Party: Yoshio Matsui, Sponsor-Investigator, Jichi Medical University
ClinicalTrials.gov Identifier: NCT01243840     History of Changes
Other Study ID Numbers: J-CARP
Study First Received: November 18, 2010
Last Updated: January 23, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013