NCT04408404

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

Same day

First QC Date

May 26, 2020

Last Update Submit

May 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Monitor peri-operative mortality incidence rates

    Mortality during peri-operative acute aortic dissection procedure

    1 day

Secondary Outcomes (1)

  • Monitor peri-operative morbidity incidence rates

    1 day

Study Arms (1)

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

Procedure: Acute aortic dissection

Interventions

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)

Type A aortic dissection

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital since the 01 January 2007 and the 31 december 2017.

You may qualify if:

  • patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital

You may not qualify if:

  • patients who died before the surgical incision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular and thoracic surgery Unit - Dijon University Hopital

Dijon, 21000, France

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 26, 2020

First Posted

May 29, 2020

Study Start

January 1, 2018

Primary Completion

January 1, 2018

Study Completion

May 26, 2020

Last Updated

May 29, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

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.

Locations