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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Tianjin Medical University General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01208116
First Posted: September 23, 2010
Last Update Posted: September 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tianjin Medical University General Hospital
  Purpose
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.

Condition Intervention
Atherosclerosis Cardiovascular Disease Other: Cardiovascular events

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study on Predictive Value of Non-Invasive Atherosclerotic Measurements in Elderly Chinese

Further study details as provided by Tianjin Medical University General Hospital:

Estimated Enrollment: 1290
Study Start Date: April 2010
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208116


Contacts
Contact: Ning Sun, M.D. +86 13820220028 ss9981@sina.com

Locations
China, Tianjin
Geriatric Department, Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300052
Contact: Ning Sun, M.D.    +86 13820220028    ss9981@sina.com   
Sponsors and Collaborators
Tianjin Medical University General Hospital
Investigators
Study Director: Ning Sun, M.D. Tianjin Medical University General Hospital
  More Information

Responsible Party: Sun Ning, Geriatrics Department, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT01208116     History of Changes
Other Study ID Numbers: B2009A055
First Submitted: September 22, 2010
First Posted: September 23, 2010
Last Update Posted: September 23, 2010
Last Verified: September 2010

Keywords provided by Tianjin Medical University General Hospital:
Atherosclerosis
Prognosis
Flow-mediated dilatation
Brachial-ankle pulse wave velocity
Carotid Intimal-Medial Thickness
coronary artery calcification score
Ankle-brachial index

Additional relevant MeSH terms:
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases