Aortic DissectionNCT04408404
Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital
An observational study of Aortic Dissection, run by Centre Hospitalier La Chartreuse at 1 site in France.
Trial summary
Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic. Global mortality remains high even if it decreased last years. This is probably due to improvement of diagnostic techniques and the evolution of surgical practices. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Acute aortic dissection
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 26 May 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital since the 01 January 2007 and the 31 december 2017.
Who may be able to join
- patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital
Who cannot join
- patients who died before the surgical incision
Trial locations and contacts
1 site in 1 country.
France1 site
Cardiovascular and thoracic surgery Unit - Dijon University Hopital
Dijon, 21000
About this study
Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic. Global mortality remains high even if it decreased last years. This is probably due to improvement of diagnostic techniques and the evolution of surgical practices. It is however important to have medical data and statistics obtained in past years in order to better understand the factors influencing peroperative mortality and thereby to continue this improvement.
- Conditions
- Aortic Dissection
- Being tested
- Acute 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.
Acute aortic dissectionProcedure or surgery
Acute aortic dissection treatment include Bentall procedure, Tyrone David procedure, Yacoub procedure or ascendant aortic replacement with or without aortic valve replacement, ascendant aortic root remodelling (all are standard of care procedures)
| Study group | Role | What they receive |
|---|---|---|
| Type A aortic dissection | Patient operated for type A acute aortic dissection between 01 January 2007 and 31 December 2017 in Dijon Burgundy University Hospital Receives: Procedure: Acute aortic dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitor peri-operative mortality incidence rates
Mortality during peri-operative acute aortic dissection procedure
Measured: 1 day
Secondary outcomes (1)
Monitor peri-operative morbidity incidence rates
Stroke, Kidney failure, Reexploration for bleeding
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2018
- Study completion26 May 2020
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier La Chartreuse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408404
- Sponsor's protocol ID
- CCVT- Dissection
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patients are informed before surgery that all the medical data included in the medical record could be used in cardiovascular monocentric retrospective study. No data shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital
- ClinicalTrials.gov ID
- NCT04408404
- Acronym / sponsor ID
- CCVT- Dissection
- Conditions
- Aortic Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Centre Hospitalier La ChartreuseUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 29 May 2020 (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.
Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic. Global mortality remains high even if it decreased last years. This is probably due to improvement of diagnostic techniques and the evolution of surgical practices. It is however important to have medical data and statistics obtained in past years in order to better understand the factors influencing peroperative mortality and thereby to continue this improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type A aortic dissection | – | Procedure: Acute aortic dissectionPatient operated for type A acute aortic dissection between 01 January 2007 and 31 December 2017 in Dijon Burgundy University Hospital |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital since the 01 January 2007 and the 31 december 2017.
Key inclusion criteria (1 listed)
- patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital
Key exclusion criteria (1 listed)
- patients who died before the surgical incision
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 |
|---|---|---|
| Acute aortic dissectionAcute aortic dissection treatment include Bentall procedure, Tyrone David procedure, Yacoub procedure or ascendant aortic replacement with or without aortic valve replacement, ascendant aortic root remodelling (all are standard of care procedures) | Procedure or surgery | Type A aortic dissection |
Primary outcome
Monitor peri-operative mortality incidence rates
Time frame: 1 day
Mortality during peri-operative acute aortic dissection procedure
1 secondary outcome
Monitor peri-operative morbidity incidence rates
Time frame: 1 day
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 29 May 2020.
- Individual participant dataSharing planned: No. All patients are informed before surgery that all the medical data included in the medical record could be used in cardiovascular monocentric retrospective study. No data shared.
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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.
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 Centre Hospitalier La Chartreuse at 1 site in France.
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 29 May 2020. 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 France. 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.
What does the primary outcome measure?
Monitor peri-operative mortality incidence rates (time frame: 1 day). 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 29 May 2020.