Persistent Blood Flow in False Lumen of Aortic DissectionNCT02267941
Risk Factors for Aortic Dissection in the Chinese Patients
An observational study of Persistent Blood Flow in False Lumen of Aortic Dissection, run by General Hospital of Beijing PLA Military Region.
Trial summary
To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Blood Flow in False Lumen of Aortic Dissection
- What is being tested?
- observation
- How many people
- 3,045 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aortic dissection
- Acute stage
Who cannot join
- -Simple aortic aneurysm and pseudoaneurysm were excluded.
About this study
Official title: Food and Drug Administration in China
To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese patients.
Read the 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.
- Being tested
- observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
Data were collected by a disigned form. Statistic software was used to analyze clinical data.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factor for aortic dissection in Chinese pupolation
Measured: Risk factor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Blood Flow in False Lumen of Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Beijing PLA Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Li, General Hospital of Beijing PLA Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267941
- Sponsor's protocol ID
- GHBeijing-20140702
- Status last verified
- Dec 2013
- First submitted
- 20 Sep 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food and Drug Administration in China
- ClinicalTrials.gov ID
- NCT02267941
- Acronym / sponsor ID
- GHBeijing-20140702
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,045 participants (actual)
- Lead sponsor
- General Hospital of Beijing PLA Military RegionUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Other: observationDiagnosis 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. |
| control | – | Other: observationAs 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Aortic dissection
- Acute stage
Key exclusion criteria (1 listed)
- -Simple aortic aneurysm and pseudoaneurysm were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationData were collected by a disigned form. Statistic software was used to analyze clinical data. | Other | case, control |
Primary outcome
Risk factor for aortic dissection in Chinese pupolation
Time frame: Risk factor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Blood Flow in False Lumen of Aortic Dissection, run by General Hospital of Beijing PLA Military Region.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factor for aortic dissection in Chinese pupolation (time frame: Risk factor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.