Aorta Thoracic Ascending DissectionCPOAADCPNCT01606943
Clinical Profiles and Outcomes of Acute Aortic Dissection in the Chinese Patients
An observational study of Aorta Thoracic Ascending Dissection and Dissection of Descending Aorta, run by Xijing Hospital at 1 site in China.
Trial summary
Clinical profiles and outcomes of patients with acute aortic dissection have not yet been evaluated in China. The aim of this study is to establish clinical registry of acute aortic dissection in China and to analyze clinical features, managements and outcomes of Chinese patients with acute aortic dissection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aorta Thoracic Ascending Dissection, Dissection of Descending Aorta
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Feb 2012
- 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: Chinese population suffering acute aortic dissection
Who may be able to join
- Stanford type A dissection
- Stanford type B dissection
- Retrograde Stanford Type B dissection
- Unclassified dissection with primary tear located in the aortic dissection
Who cannot join
- Aortic aneurysm
- Active infection or active vasculitides
- Myocardial infarction or Cerebral accident within 2 months
- Unwillingness to cooperate wiht study procedures or follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study of The Chinese Registry of Acute Aortic Dissection and Clinical Study of Acute Aortic Dissection in Chinese Patients
Clinical profiles and outcomes of patients with acute aortic dissection have not yet been evaluated in China. The aim of this study is to establish clinical registry of acute aortic dissection in China and to analyze clinical features, managements and outcomes of Chinese patients with acute aortic dissection.
Read the detailed description
In 1996, the Internation Registry of Acute Aortic Dissection(IRAD) was established to improve clinical diagnosis and treatment of acute aortic dissection. However, most patients from the IRAD are Caucasian. These data were not sufficient to reflect clinical profiles and outcomes of Chinese patients with acute aortic dissection. In China, little is known about clinical features, managements and outcomes of acute aortic dissection involving a large number of patients. The investigators established clinical multicenter registry of acute aortic dissection. Between January 2009 and February 2012, about 2000 were enrolled in the Chinese registry of acute aortic dissection(CRAD) database. The aim of this study is to analyze clinical profiles and outcomes of Chinese patients with acute aortic dissection.
- Keywords
- Aortic dissection, Risk factor, Feature, Management, Outcome
- Medical subject headings
- Dissection, Thoracic Aorta, Aortic Dissection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startJan 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorta Thoracic Ascending DissectionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital
- Responsible party
- Principal investigator, Yang Li, MD, Xijing Hospital
- Investigators
- Dihua Yi, MD, Study director, Xijing HospitalYang Li, MD, Principal investigator, General Hospital of Beijing Military Area command of Chinese PLAWenxun Duan, MD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606943
- Sponsor's protocol ID
- XJ201202
- Other IDs
- CRAD2011
- Acronym
- CPOAADCP
- Status last verified
- May 2012
- First submitted
- 1 Mar 2012
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of The Chinese Registry of Acute Aortic Dissection and Clinical Study of Acute Aortic Dissection in Chinese Patients
- ClinicalTrials.gov ID
- NCT01606943
- Acronym / sponsor ID
- CPOAADCP / XJ201202
- Keywords
- Aortic dissection, Risk factor, Feature, Management, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital
- Study start
- Jan 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 May 2012 (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.
Clinical profiles and outcomes of patients with acute aortic dissection have not yet been evaluated in China. The aim of this study is to establish clinical registry of acute aortic dissection in China and to analyze clinical features, managements and outcomes of Chinese patients with acute aortic dissection.
Detailed description
In 1996, the Internation Registry of Acute Aortic Dissection(IRAD) was established to improve clinical diagnosis and treatment of acute aortic dissection. However, most patients from the IRAD are Caucasian. These data were not sufficient to reflect clinical profiles and outcomes of Chinese patients with acute aortic dissection. In China, little is known about clinical features, managements and outcomes of acute aortic dissection involving a large number of patients. The investigators established clinical multicenter registry of acute aortic dissection. Between January 2009 and February 2012, about 2000 were enrolled in the Chinese registry of acute aortic dissection(CRAD) database. The aim of this study is to analyze clinical profiles and outcomes of Chinese patients with acute aortic dissection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese population suffering acute aortic dissection
Key inclusion criteria (4 listed)
- Stanford type A dissection
- Stanford type B dissection
- Retrograde Stanford Type B dissection
- Unclassified dissection with primary tear located in the aortic dissection
Key exclusion criteria (4 listed)
- Aortic aneurysm
- Active infection or active vasculitides
- Myocardial infarction or Cerebral accident within 2 months
- Unwillingness to cooperate wiht study procedures or follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 28 May 2012.
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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.
Dihua Yi, MD study director
Xijing Hospital
Yang Li, MD principal investigator
General Hospital of Beijing Military Area command of Chinese PLA
Wenxun Duan, MD principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aorta Thoracic Ascending Dissection and Dissection of Descending Aorta, run by Xijing Hospital at 1 site in China.
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 4 inclusion and 4 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 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 28 May 2012.