Aortic DissectionCCMOCPAADNCT01552720
Clinical Characteristics, Management and Outcomes of Chinese Patients With Acute Aortic Dissection
An observational study of Aortic Dissection, run by Xijing Hospital at 1 site in China.
Trial summary
Data reported by the international registry of acute aortic dissection (IRAD) in not sufficient to reflect clinical characteristics of acute aortic dissection in China. Moreover, clinical characteristics of Acute aortic dissection have not evaluated to data. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2015
- 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 patients suffering acute aortic dissection
Who may be able to join
- Clinical diagnosis of acute aortic dissection
- Type A dissection
- Type B dissection
- Retrograde type B dissection
Who cannot join
- Aortic aneurysm
- Myocardial infarction
- Cerebral accident
- Active infection
- Unwillingness to cooperation with study procedures or follow-up visits
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Yang Li, MD, 029-68574562, liyangcenter@sina.com
Yang Li, MD
About this study
Official title: Clinical Investigation of Chinese Patients With Aortic Dissection
Data reported by the international registry of acute aortic dissection (IRAD) in not sufficient to reflect clinical characteristics of acute aortic dissection in China. Moreover, clinical characteristics of Acute aortic dissection have not evaluated to data. The aim of this study is analyze changing trend of clinical characteristics of Chinese patients with acute aortic dissection.
Read the detailed description
Acute aortic dissection is the most common aortic emergency, with an annual incidence of 3-5 cases per 100 000 population. About 50% of these patients are dead within 48 hours, if untreated. To assess the clinical manifestation, diagnosis, management, and outcomes of patients with AAD, the International Registry of Acute Aortic Dissection (IRAD) was established in 1996, and has grown to include about 2000 patients from 26 large referral centers to date. All patients from IRAD are caucasians from developed countries wiht advanced medical care, however, the proportion of Asian is very low. Data reported by the IRAD in not sufficient to reflect clinical characteristics of Acute aortic dissection in China. Clinical characteristics of Chinese patients with acute aortic dissection have not evaluated to data. The aim of this study is to analyze clinical characteristics of Chinese patients with acute aortic dissection and clinical trend of acute aortic dissection.
- Conditions
- Aortic Dissection
- Keywords
- aorta, dissection, feature
- Medical subject headings
- Aortic Dissection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Li, MD, Xijing Hospital
- Investigators
- Dihua Yi, PhD, MD, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552720
- Sponsor's protocol ID
- XJHEART2012
- Other IDs
- CRAD201203
- Acronym
- CCMOCPAAD
- Status last verified
- Mar 2012
- First submitted
- 7 Mar 2012
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Chinese Patients With Aortic Dissection
- ClinicalTrials.gov ID
- NCT01552720
- Acronym / sponsor ID
- CCMOCPAAD / XJHEART2012
- Conditions
- Aortic Dissection
- Keywords
- aorta, dissection, feature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 Mar 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.
Data reported by the international registry of acute aortic dissection (IRAD) in not sufficient to reflect clinical characteristics of acute aortic dissection in China. Moreover, clinical characteristics of Acute aortic dissection have not evaluated to data. The aim of this study is analyze changing trend of clinical characteristics of Chinese patients with acute aortic dissection.
Detailed description
Acute aortic dissection is the most common aortic emergency, with an annual incidence of 3-5 cases per 100 000 population. About 50% of these patients are dead within 48 hours, if untreated. To assess the clinical manifestation, diagnosis, management, and outcomes of patients with AAD, the International Registry of Acute Aortic Dissection (IRAD) was established in 1996, and has grown to include about 2000 patients from 26 large referral centers to date. All patients from IRAD are caucasians from developed countries wiht advanced medical care, however, the proportion of Asian is very low. Data reported by the IRAD in not sufficient to reflect clinical characteristics of Acute aortic dissection in China. Clinical characteristics of Chinese patients with acute aortic dissection have not evaluated to data. The aim of this study is to analyze clinical characteristics of Chinese patients with acute aortic dissection and clinical trend of acute aortic dissection.
Study design
- Observational model
- Case only
- 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 patients suffering acute aortic dissection
Key inclusion criteria (4 listed)
- Clinical diagnosis of acute aortic dissection
- Type A dissection
- Type B dissection
- Retrograde type B dissection
Key exclusion criteria (5 listed)
- Aortic aneurysm
- Myocardial infarction
- Cerebral accident
- Active infection
- Unwillingness to cooperation with 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
- databaseLink provided by the sponsor.
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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, PhD, MD study director
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 Aortic Dissection, 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 5 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: status not confirmed, as of the sponsor's last update on 13 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Li, MD (029-6787564, liyangcenter@sina.com), or a site near the patient. 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 13 Mar 2012.