NCT02267941

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,045

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
Last Updated

October 20, 2014

Status Verified

December 1, 2013

Enrollment Period

Same day

First QC Date

September 20, 2014

Last Update Submit

October 15, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Risk factor for aortic dissection in Chinese pupolation

    Risk factor

Study Arms (2)

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.

Other: observation

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.

Other: observation

Interventions

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

casecontrol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Between January, 2011 and December, 2012, we collected 3045 patients with AAD (1668 with type A and 1377 with type B) from 15 major centers in China as the case group. As the control group, 2760 patients without AD were obtained from the hospitalized patients in the same period.

You may qualify if:

  • Aortic dissection
  • Acute stage

You may not qualify if:

  • Simple aortic aneurysm and pseudoaneurysm were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 20, 2014

First Posted

October 20, 2014

Study Start

January 1, 2011

Primary Completion

January 1, 2011

Study Completion

December 1, 2013

Last Updated

October 20, 2014

Record last verified: 2013-12