The Epidemiology of Aortic Diameter in China

Hypertension Clinical Trial

Official title:

Epidemiology of Aortic Dimensions in Patients With Clinically Evident Arterial Disease or Cardiovascular Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00820378
• Other study ID #: EPAD
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2009
• Last updated: January 12, 2009
• Start date: January 2009
• Est. completion date: December 2015

Study information

• Verified date: January 2009
• Source: Zhejiang University
• Contact: Xiao-feng Chen, MD.
• Phone: 86-13656680890
• Email: zjxiaofengchen[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Aortic aneurysms are the major disease processes affecting the aorta and becoming a relatively common cause of death because of rupture or dissection. The most common location for aneurysms is the infrarenal abdominal aorta, followed by the ascending thoracic aorta. Unlike coronary heart disease, the incidence of abdominal aortic aneurysm (AAA) in the United States and Europe has been increasing, and this increase may not be due to higher levels of screening for this condition alone. Aortic diameter is central to the diagnosis of aortic aneurysm. Furthermore, it was demonstrated that non-AAA patients with an enlarged diameter of the infrarenal aortic diameter are also at high risk for all-cause mortality. And aortic root dimension was associated with several coronary artery disease (CHD) risk factors and measures of subclinical disease and was predictive of incident congestive heart failure (CHF), stroke, cardiovascular disease (CVD) mortality, and all-cause mortality, but not of incident MI. Up to now, there are limited studies on the epidemiology of aortic diameter, especially in Chinese population.

Description:

The purpose of this study was to analyze the size of the entire aorta at different anatomic levels in a large group of Chinese population with clinically evident arterial disease or cardiovascular risk factors to further explored the risk factors and potential alternative pathomechanisms for the development of aortic dilatation. Comprehensive transthoracic M-mode, 2-dimensional, and Doppler echocardiographic studies will be performed using commercially available equipment. The aortic dimensions were assessed at end-diastole at the different levels: (1) the annulus, (2) the mid-point of the sinuses of Valsalva, (3) the sinotubular junction, (4) the ascending aorta at the level of its largest diameter, (5) the transverse arch, (6) the descending aorta posterior to the left atrium, and (7) the abdominal aorta just distal to the origin of the renal arteries. The extension of dilation is defined as the number of dilated aortic segments. The relations among aortic dimensions and clinical characteristics will be assessed by multiple regression analysis. The current study was to determine the association of risk factors of CVD and atherosclerosis diseases with aortic dimension in Chinese patients with clinical event atherosclerotic disease or risk factors of atherosclerotic disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2015
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 40 to 100 were referred to the hospital with a recent diagnosis of clinically evident arterial disease or a cardiovascular risk factor.

Exclusion Criteria:

• Those with connective tissue disease, congenital heart disease, cardiomyopathy, congestive heart failure,rheumatic arthritis, secondary causes of hypertension, or active cancer.

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Vascular Disease
• Vascular Diseases

Intervention

Other:
• No special interventioin
Comprehensive transthoracic M-mode, 2-dimensional, and Doppler echocardiographic studies will be performed using commercially available equipment. The aortic dimensions were assessed at end-diastole at the different levels:

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University College of Medicine	Hangzhou	Zhejiang
China	Taizhou Hospital, Wenzhou Medical College	Taizhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Taizhou Hospital

Country where clinical trial is conducted

China,