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

September 22, 2010 updated by: Tianjin Medical University General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

1290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Geriatric Department, Tianjin Medical University General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with an age>=60 years, who are designated for healthcare in Tianjin Medical University General Hospital will be enrolled in the study and there is no restriction on gender. Medical histroy are recorded precisely. The protocol was approved by our Institutional Ethics Committee and all subjects give informed consent before participating.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subgroups
According to the demographic features, subjects may be divided into some subgroups.
Other: Cardiovascular events
  • Coronary intervention
  • Infarction
  • Congestive heart failure
  • Stroke
  • Cardiac death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University General Hospital

Investigators

  • Study Director: Ning Sun, M.D., Tianjin Medical University General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Study Registration Dates

First Submitted

September 22, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (Estimate)

September 23, 2010

Study Record Updates

Last Update Posted (Estimate)

September 23, 2010

Last Update Submitted That Met QC Criteria

September 22, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2009A055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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