Japan Central Aortic Pressure Prospective Study

NCT01243840 | Unknown

• 1 other identifier: J-CARP
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the study

1. 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. 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. 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. 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.

Conditions

Healthy

Keywords

Central aortic pressure; Aortic pulse wave velocity; Aortic PWV using a single pressure recording; Vascular aging; Left ventricular hypertrophy; Left ventricular diastolic function

Outcome Measures

Primary Outcomes (1)

• •Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure

  5 years

Secondary Outcomes (1)

• New onset of hypertension, diabetes mellitus, or atrial fibrillation

  5 years

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Subjects who visit hospital for their health checks
• Healthy volunteers who agree to participate in this study

You may not qualify if:

• 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

Sponsors & Collaborators

• Yoshio Matsui: lead

Study Sites (1)

Iwakuni City Medical Center

Iwakuni, Yamaguchi, 740-0021, Japan

RECRUITING

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kazuomi Kario, MD

  Jichi Medical University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2019
• Last Updated: January 25, 2012

Record last verified: 2010-06

Locations

JP (1)