A Prospective Study on Predictive Value of Non-Invasive Atherosclerotic Measurements in Elderly Chinese

NCT ID: NCT01208116

Last Updated: 2010-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Brief Summary

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The purpose of this study is to determine whether non-invasive atherosclerotic measurements (baPWV, IMT, FMD, CACS, ABI) are valuable predictors for cardiovascular events in elderly. At inception, routine physical examination and non-invasive atherosclerotic measurements will conducted on all participants. Then they will be followed prospectively for at least 2 years. All cardiovascular and other health events will be recorded.

Detailed Description

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Cardiovascular disease is the most common cause of morbidity and mortality in the world, especially in elderly. Conventional risk factors are widely used in clinical practice, but it is inadequate and inaccurate due to no direct evaluation of artery. However, invasive method, it is difficult to be applied in atherosclerosis screening and only used in advanced institutions, is expensive and unacceptable. We are trying to assess the value of noninvasive measurements in predicting cardiovascular events.

Five invasive methods will be applied in the study, including

* brachial-ankle Pulse Wave Velocity(baPWV)
* Carotid Intimal-Medial Thickness(CIMT)
* Flow Mediated Dilation(FMD)
* Ankle-Brachial Index(ABI)
* Coronary Artery Calcification Score(CACS)

These indices represent not only different phase of atherosclerosis, but also various sections and arterial layers.

Conditions

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Atherosclerosis Cardiovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subgroups

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Cardiovascular events

Intervention Type OTHER

* Coronary intervention
* Infarction
* Congestive heart failure
* Stroke
* Cardiac death

Interventions

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Cardiovascular events

* Coronary intervention
* Infarction
* Congestive heart failure
* Stroke
* Cardiac death

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chinese, age\>=60, no gender restriction.
* To be able to apply the measurement mentioned above.
* Medical history are maintained precisely.
* Tianjin Medical University General Hospital is the participants' designated hospital by national health authority.

Exclusion Criteria

* Systemic inflammation.
* Malignant tumor
* Chronic lung disease
* Liver disease
* Aortic aneurysm
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Geriatrics Department, Tianjin Medical University General Hospital

Principal Investigators

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Ning Sun, M.D.

Role: STUDY_DIRECTOR

Tianjin Medical University General Hospital

Locations

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Geriatric Department, Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ning Sun, M.D.

Role: CONTACT

+86 13820220028

Facility Contacts

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Ning Sun, M.D.

Role: primary

+86 13820220028

Other Identifiers

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B2009A055

Identifier Type: -

Identifier Source: org_study_id