Acute Aortic DissectionNCT03381716
Correlation Between Sex and Prognosis of Acute Aortic Dissection in the Chinese Population
An observational study of Acute Aortic Dissection and Sex Role, run by Shenyang Northern Hospital.
Trial summary
The study evaluated the prevalence, presentation, management, and prognosis of coronary heart disease differ according to sex. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Acute Aortic Dissection, Sex Role
- What is being tested?
- drug and Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 884 participants
- Where
- No sites listed yet
- Study dates
- 19 Jun 2002to 29 May 2016
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese
Who may be able to join
- acute aortic dissection
Who cannot join
- Chronic aortic dissection
About this study
The study evaluated the prevalence, presentation, management, and prognosis of coronary heart disease differ according to sex.
Read the detailed description
The study included 884 patients enrolled in our institute between June 2002 and May 2016. Considering psychosocial factors, treatments, and the outcomes in men versus those in women with acute aortic dissection, explored the association of sex with psychosocial characteristics and mortality risk. Of 884 patients, 211 (23.9%) were women. The median duration of follow-up was 2.9 years (25th -75th percentiles: 1-4 years ).
- Conditions
- Acute Aortic Dissection, Sex Role
- Being tested
- drug, Surgery
- Keywords
- aortic dissection, sex, treatment
- Medical subject headings
- Aortic Dissection, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drugDrug
Also called thoracic endovascular aortic repair
Application bracket
SurgeryProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| male | Drug:Beta-blocker,Angiotensin II receptor blocker,Angiotensin-converting enzyme,Calcium-channel blocker,Aspirin,Statin Receives: Drug: drug; Procedure: Surgery | |
| female | Drug:Beta-blocker,Angiotensin II receptor blocker,Angiotensin-converting enzyme,Calcium-channel blocker,Aspirin,Statin Receives: Drug: drug; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome measure describes aortic disease-related death，aortic dissection, paraplegia, myocardial ischemia, renal insufficiency and other aortic complications.
The study's primary endpoint during the follow up was the composite of aortic disease-related death, aortic dissection, paraplegia, myocardial ischemia, renal insufficiency and other aortic complications during follow-up.
Measured: 2.9years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start19 Jun 2002
- Primary completion29 May 2016
- Study completion29 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 884 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, MD, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381716
- Sponsor's protocol ID
- SYNH-20171207
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bossone E, LaBounty TM, Eagle KA. Acute aortic syndromes: diagnosis and management, an update. Eur Heart J. 2018 Mar 1;39(9):739-749d. doi: 10.1093/eurheartj/ehx319.
PubMed 29106452
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Sex and Prognosis of Acute Aortic Dissection in the Chinese Population
- ClinicalTrials.gov ID
- NCT03381716
- Acronym / sponsor ID
- SYNH-20171207
- Conditions
- Acute Aortic Dissection, Sex Role
- Keywords
- aortic dissection, sex, treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 884 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 19 Jun 2002 (actual)
- Primary completion
- 29 May 2016 (actual)
- Study completion
- 29 May 2016 (actual)
- First posted
- 22 Dec 2017 (actual)
- 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 study evaluated the prevalence, presentation, management, and prognosis of coronary heart disease differ according to sex.
Detailed description
The study included 884 patients enrolled in our institute between June 2002 and May 2016. Considering psychosocial factors, treatments, and the outcomes in men versus those in women with acute aortic dissection, explored the association of sex with psychosocial characteristics and mortality risk. Of 884 patients, 211 (23.9%) were women. The median duration of follow-up was 2.9 years (25th -75th percentiles: 1-4 years ).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| male | – | Drug: drug, Procedure: SurgeryDrug:Beta-blocker,Angiotensin II receptor blocker,Angiotensin-converting enzyme,Calcium-channel blocker,Aspirin,Statin |
| female | – | Drug: drug, Procedure: SurgeryDrug:Beta-blocker,Angiotensin II receptor blocker,Angiotensin-converting enzyme,Calcium-channel blocker,Aspirin,Statin |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (1 listed)
- acute aortic dissection
Key exclusion criteria (1 listed)
- Chronic aortic dissection
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 |
|---|---|---|
| drugAlso: thoracic endovascular aortic repairApplication bracket | Drug | female, male |
| SurgerySurgery | Procedure or surgery | female, male |
Primary outcome
The outcome measure describes aortic disease-related death，aortic dissection, paraplegia, myocardial ischemia, renal insufficiency and other aortic complications.
Time frame: 2.9years
The study's primary endpoint during the follow up was the composite of aortic disease-related death, aortic dissection, paraplegia, myocardial ischemia, renal insufficiency and other aortic complications during follow-up.
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 22 Dec 2017.
- Results publication: PubMed 29106452Bossone E, LaBounty TM, Eagle KA. Acute aortic syndromes: diagnosis and management, an update. Eur Heart J. 2018 Mar 1;39(9):739-749d. doi: 10.1093/eurheartj/ehx319.
- Individual participant dataSharing planned: No
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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.
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 Acute Aortic Dissection and Sex Role, run by Shenyang Northern Hospital.
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 1 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 22 Dec 2017. 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?
The outcome measure describes aortic disease-related death，aortic dissection, paraplegia, myocardial ischemia, renal insufficiency and other aortic complications. (time frame: 2.9years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03381716, which also lists 1 linked publication.
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 22 Dec 2017.