Pre-hospital Management of Aortic Dissection (FFDA)

March 19, 2020 updated by: Centre Hospitalier Universitaire de Besancon

Non Traumatic Aortic Dissection : Chain of Care and Pre-hospital Risk Factors, a Retrospective, Multicenter Study

Background :

Time between symptoms onset and treatment initiation is crucial in Acute aortic dissection (AAD). An anti-hypertensive treatment can be rapidly initiated before the arrival in Emergency Department (ED). A better understanding of the chain of care between symptoms onset and surgery could lead to a reduction of morbi-mortality. Our study have the objective to describe the chain of care of patients with AAD in the ED.

Methods :

This is an observational, retrospective, multicenter study. Patients were detected with a discharge of diagnostic of aortic dissection (ICD I71.0) in university medical center of Besançon. Data collection : patients records in the 8 hospitals centers of the area Franche-Comté.

Study Overview

Status

Unknown

Conditions

Detailed Description

Acute aortic dissection (AAD) is the most lethal vascular emergency. AAD remains a challenge to diagnose and to treat even for experienced practitioners. AAD identification and treatment administration greatly improve morbidity and mortality associated to AAD. The diagnosis of AAD is particularly challenging, due to a combination of highly heterogeneous clinical presentation and low incidence (3-5 cases/100,000 individuals/year). Clinical guidelines suggest that AAD should be considered in all patients presenting with chest pain, back pain, abdominal pain, syncope or symptoms consistent with perfusion deficit, but these symptoms account for large proportions of emergency medical visits. CT-scan is validated and increasedly available for confirming or ruling out AAD. Stanford classification is most current use, with two groups : type A involve the ascending aorta, type B don't involve the ascending aorta until the arch. The majority of type A is managed surgically, but the majority of type B is managed medically with anti-hypertensive treatment. Aortic dissection can be classified into hyperacute (from symptom onset to 24 hours), acute (2-7 days), subacute (8-30 days), and chronic (> 30 days). Booher et al, suggested that acute and sub-acute aortic dissection make the majority of the mortality rate.

Mortality among patients with a Stanfond Type A dissection is 1 to 2 percent per hour, early after symptom onset. In-hospital mortality is highly dependent on patient risk profiles before surgery. Patient with a history of aortic valve replacement, a migrating chest pain, a tamponade, an hypotension or a limb ischemia are associated to a higher in-hospital mortality.

Time between symptoms onset and treatment initiation is crucial. The diagnosis can be suspected by the family physician. In France, diagnosis can be also suspected by the MICU (Mobile Intensive Care Unit). An anti-hypertensive treatment can be rapidly initiated before the arrival by the ED, and the diagnosis is confirmed by CT-scan. In the Harris' study, median time from arrival at the emergency department to diagnosis and from diagnosis to surgery were 4.3 hours. To our knowledge no study investigated the pre-hospital phase, especially the impact of the methods and vectors used. A better understanding of the chain of care from symptoms onset to surgery could lead to a reduction of morbi-mortality. Our study aimed the objective to describe the chain of care of patients with AAD in the ED of eight hospitals centers of area of Franche-Comté (France) between 2010 and 2019.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients supported for an AAD between 2010-2019 in one of height hospitals centers participants.

Description

Inclusion Criteria :

  • patients with age > 18 years
  • patients with the diagnosis of non traumatic acute aortic dissection
  • patients hospitalized in the university medical center

Exclusion Criteria :

  • decision of withdrawal life support
  • patients that died without a diagnosis confirmation with Helical Computed Tomography (HCT), Magnetic Resonnance Imagery (MRI), TransEsophageal Echocardiography (TEE) or surgery/autopsy
  • AAD that were complications of coronarography or aortic surgery
  • lack of information
  • patient opposition to study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality rate
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Hopital Nord Franche-Comte
Centre Hospitalier de Lons Le Saunier
Centre hospitalier de Vesoul
Centre hospitalier de Pontarlier
Centre hospitalier de Gray
Centre hospitalier de Dole
Centre Hospitalier de Saint-Claude

Investigators

  • Principal Investigator: Christian Daguerre, MD-student, CHU de Besancon
  • Study Director: Antoine Sigaux, MD, CHU de Besancon
  • Study Chair: Thibaut Desmettre, MD, PHD, CHU de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2019/453

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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