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NCT01208116 Clinical Trial

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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01208116
Other study ID # B2009A055
Secondary ID
Status Recruiting
Phase N/A
First received September 22, 2010
Last updated September 22, 2010
Start date April 2010

Study information
Verified date September 2010
Source Tianjin Medical University General Hospital
Contact Ning Sun, M.D.
Phone +86 13820220028
Email ss9981@sina.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1290
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Cardiovascular events
Coronary intervention Infarction Congestive heart failure Stroke Cardiac death

Locations
Country Name City State
China Geriatric Department, Tianjin Medical University General Hospital Tianjin Tianjin

Sponsors (1)
Lead Sponsor Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

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