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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 because the information has not been verified recently.
Verified September 2010 by Tianjin Medical University General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier:
NCT01208116
First received: September 22, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sun Ning, Geriatrics Department, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT01208116     History of Changes
Other Study ID Numbers: B2009A055
Study First Received: September 22, 2010
Last Updated: September 22, 2010
Health Authority: China: Ministry of Health

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:
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013