HealthyJ-CARPNCT01243840
Japan Central Aortic Pressure Prospective Study
An observational study of Healthy, run by Yoshio Matsui at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 3,000 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2010to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ages eligible for Study: 20 Years to 90 Years Genders eligible for Study: Both Accepts healthy volunteers: Yes
Who may be able to join
- Subjects who visit hospital for their health checks
- Healthy volunteers who agree to participate in this study
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Iwakuni City Medical Center
Iwakuni, Yamaguchi, 740-0021
Yoshio Matsui, +81-827-21-3211, yoshio@jichi.ac.jp
Yoshio Matsui, MD
About this study
Official title: Central Blood Pressure Follow-up Study in Japanese
Purpose of the study
- 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.
- 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.
- 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.
- 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
- Medical subject headings
- Hypertrophy, Left Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
•Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure
Measured: 5 years
Secondary outcomes (1)
New onset of hypertension, diabetes mellitus, or atrial fibrillation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2014 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yoshio Matsui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yoshio Matsui, Jichi Medical University
- Investigators
- Kazuomi Kario, MD, Study director, Jichi Medical University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243840
- Sponsor's protocol ID
- J-CARP
- Acronym
- J-CARP
- Status last verified
- Jun 2010
- First submitted
- 18 Nov 2010
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Blood Pressure Follow-up Study in Japanese
- ClinicalTrials.gov ID
- NCT01243840
- Acronym / sponsor ID
- J-CARP / J-CARP
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Yoshio MatsuiUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ages eligible for Study: 20 Years to 90 Years Genders eligible for Study: Both Accepts healthy volunteers: Yes
Key inclusion criteria (2 listed)
- Subjects who visit hospital for their health checks
- Healthy volunteers who agree to participate in this study
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
•Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure
Time frame: 5 years
1 secondary outcome
New onset of hypertension, diabetes mellitus, or atrial fibrillation
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuomi Kario, MD study director
Jichi Medical University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Yoshio Matsui at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
•Composite of following events: sudden death, cardiovascular death, stroke, coronary events, heart failure (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2012.