Risk Factors for Aortic Dissection in the Chinese Patients

NCT ID: NCT02267941

Last Updated: 2014-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3045 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-12-31

Brief Summary

To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese patients.

Detailed Description

Aortic dissection (AD) is a life-threatening cardiovascular disease with high mortality. Without optimal treatment, approximately 50% of patients die within one week of the onset of symptoms, and 80% die within 2 weeks. With the change of life-style and the development of diagnostic technology, the incidence and detection rate of AD were increasing in China recently. However, the cause remains unclear. Studies showed that AD were associated with some risk factors, such as hypertension, connective tissue disease, iatrogenic injury, drug, pregnancy, etc. It is reported that two thirds patients with AD had a history of hypertension; 50% patients aged <40 years were accompanied with hereditary Marfan syndrome; 13～19% had a familial history of aortic aneurysm or dissection. These epidemiological data were obtained from Caucasian population, however, such information was not available for the Chinese population. Moreover, epidemiological investigation was absent in China, and the assessment of risk factors for AD was mainly referred to the studies from developed countries. Therefore, the aim of our study was to evaluate epidemiological features of risk factors for AD in Chinese patients using 3045 individuals from the 15 major centers in China. We anticipated that this analysis would provide helpful information preventing and controlling AD in China.

Conditions

Persistent Blood Flow in False Lumen of Aortic Dissection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

case

Diagnosis of aortic dissection was based on history and physical examination, and confirmed by imaging, visualization at surgery, and/or postmortem examination. According to the Stanford classification system, type A aortic dissection was defined as any dissection that involves the ascending aorta and type B as any that does not. Acute stage was confined to initial 14 days after symptom onset. Simple aortic aneurysm and pseudoaneurysm were excluded. Surgical and endovascular treatments were the main interventions and performed in the case group.

observation

Intervention Type: OTHER

Data were collected by a disigned form. Statistic software was used to analyze clinical data.

control

As the control group, 2760 patients without AD were obtained from the hospitalized patients in the same period. Types of disease in the control group included congenital heart disease (632), coronary heart disease (467), adult valve disease (375), pulmonary artery hypertension (292), appendicitis (234), pneumonia (197), fracture (189), intestinal polyps (167), gallstone (156), esophagus cancer (51). Patients in the control group were derived from Department of Cardiovascular Surgery, Department of General Surgery, Department of Thoracic Surgery, and Department of Respiration, respectively.

observation

Intervention Type: OTHER

Data were collected by a disigned form. Statistic software was used to analyze clinical data.

Interventions

observation

Data were collected by a disigned form. Statistic software was used to analyze clinical data.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aortic dissection
• Acute stage

Exclusion Criteria

-Simple aortic aneurysm and pseudoaneurysm were excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Beijing PLA Military Region

OTHER

Sponsor Role: lead

Responsible Party

Yang Li

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GHBeijing-20140702

Identifier Type: -

Identifier Source: org_study_id