Aortic DissectionNCT01782534
Logistic Regression of Risk Factor for the 5-year Mortality of Aortic Dissection
An observational study of Aortic Dissection, run by Central South University.
Trial summary
The relevant predictive hospital risk factors for 5-year mortality of patients with aortic dissection is untill unlear. The aim of this study is to collect the clinical data of 111 hospitalized patients admitted to hospital from Aug. 2001 to Aug. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Aug 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: diagnosed AD patients in Our hospital From August 2001 to August2007
Who may be able to join
- Stanford type A dissection
- Stanford type B dissection
Who cannot join
None listed.
About this study
The relevant predictive hospital risk factors for 5-year mortality of patients with aortic dissection is untill unlear. The aim of this study is to collect the clinical data of 111 hospitalized patients admitted to hospital from Aug. 2001 to Aug. 2007, and statistically analyze the hospital risk factors related to 5-year mortality by univariate and multivariate binary logistic regression.
Read the detailed description
Clinical data were collected from 111 hospitalized patients admitted to hospital from Aug. 2001 to Aug.2007, and the related factors for death within 5 years after the onset of dissection, which include Gender, age, history of smoking, hypertension, diabetes, renal insufficiency (azotemia), low admission diastolic blood pressure (<70mmHg), Stanford typing (Stanford A or B), long-acting calcium channel blocker treatment,ACEI /ARB treatment, endovascular stent and surgical aortic replacement,were statistically analyzed by univariate and multivariate binary logistic regression.
- Conditions
- Aortic Dissection
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| aortic dissection | aortic dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
death after 5 years after the onset of dissection
participants have been followed for 5 years after the onset of dissection
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startAug 2002
- Primary completionAug 2012
- Study completionAug 2012
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.
- 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhishan SUN, Central South University
- Investigators
- Zhishan SUN, doctor, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782534
- Sponsor's protocol ID
- LR-RF-AD
- Status last verified
- Feb 2013
- First submitted
- 4 Jan 2013
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Logistic Regression of Risk Factor for the 5-year Mortality of Aortic Dissection
- ClinicalTrials.gov ID
- NCT01782534
- Acronym / sponsor ID
- LR-RF-AD
- Conditions
- Aortic Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Feb 2013 (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.
The relevant predictive hospital risk factors for 5-year mortality of patients with aortic dissection is untill unlear. The aim of this study is to collect the clinical data of 111 hospitalized patients admitted to hospital from Aug. 2001 to Aug. 2007, and statistically analyze the hospital risk factors related to 5-year mortality by univariate and multivariate binary logistic regression.
Detailed description
Clinical data were collected from 111 hospitalized patients admitted to hospital from Aug. 2001 to Aug.2007, and the related factors for death within 5 years after the onset of dissection, which include Gender, age, history of smoking, hypertension, diabetes, renal insufficiency (azotemia), low admission diastolic blood pressure (<70mmHg), Stanford typing (Stanford A or B), long-acting calcium channel blocker treatment,ACEI /ARB treatment, endovascular stent and surgical aortic replacement,were statistically analyzed by univariate and multivariate binary logistic regression.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aortic dissection | – | –aortic dissection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diagnosed AD patients in Our hospital From August 2001 to August2007
Key inclusion criteria (2 listed)
- Stanford type A dissection
- Stanford type B dissection
Key exclusion criteria (0 listed)
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
death after 5 years after the onset of dissection
Time frame: 5 years
participants have been followed for 5 years after the onset of dissection
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 26 Feb 2013.
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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.
Zhishan SUN, doctor principal investigator
Central South University
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by Central South University.
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 0 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 26 Feb 2013. 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?
death after 5 years after the onset of dissection (time frame: 5 years). 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 26 Feb 2013.