Clinical trial NCT01208116: A Prospective Study on Predictive Value of Non-Invasive Atherosclerotic Measurements in Elderly Chinese
Official title: A Prospective Study on Predictive Value of Non-Invasive Atherosclerotic Measurements in Elderly Chinese
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Cardiovascular Disease
Keywords: Atherosclerosis
Prognosis
Flow-mediated dilatation
Brachial-ankle pulse wave velocity
Carotid Intimal-Medial Thickness
coronary artery calcification score
Ankle-brachial index
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2010-09-23
Enrollment: 1290
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Geriatric Department, Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Ning Sun, M.D.
role: STUDY_DIRECTOR
References: