Aortic DissectionFFDANCT04304443
Pre-hospital Management of Aortic Dissection
An observational study of Aortic Dissection, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2020to 1 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients supported for an AAD between 2010-2019 in one of height hospitals centers participants.
Who may be able to join
- patients with age > 18 years
- patients with the diagnosis of non traumatic acute aortic dissection
- patients hospitalized in the university medical center
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Christian DAGUERRE, MD-student, +33 3 81 66 89 51, daguerrechristian@laposte.net
Antoine SIGAUX, MD, +33 3 81 66 89 51, asigaux@chu-besancon.fr
- Recruiting
Hôpital Nord Franche-Comté
Trévenans, 90400
Charles-Eric LAVOIGNET, MD, Charles-Eric.LAVOIGNET@hnfc.fr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Aortic Dissection
- Keywords
- Aortic Dissection, Mortality, Treatment delay, Emergency, Pre-hospital phase
- Medical subject headings
- Aortic Dissection, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Mar 2020
- Primary completion1 May 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Christian Daguerre, MD-student, Principal investigator, CHU de BesançonAntoine Sigaux, MD, Study director, CHU de BesançonThibaut Desmettre, MD, PHD, Study chair, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304443
- Sponsor's protocol ID
- P/2019/453
- Acronym
- FFDA
- Status last verified
- Feb 2020
- First submitted
- 9 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Axelsson C, Karlsson T, Pande K, Wigertz K, Ortenwall P, Nordanstig J, Herlitz J. A description of the prehospital phase of aortic dissection in terms of early suspicion and treatment. Prehosp Disaster Med. 2015 Apr;30(2):155-62. doi: 10.1017/S1049023X15000060. Epub 2015 Feb 10.
PubMed 25668482Dixon M. Misdiagnosing aortic dissection: a fatal mistake. J Vasc Nurs. 2011 Dec;29(4):139-46. doi: 10.1016/j.jvn.2011.08.003.
PubMed 22062792Nazerian P, Giachino F, Vanni S, Veglio MG, Castelli M, Lison D, Bitossi L, Moiraghi C, Grifoni S, Morello F. Diagnostic performance of the aortic dissection detection risk score in patients with suspected acute aortic dissection. Eur Heart J Acute Cardiovasc Care. 2014 Dec;3(4):373-81. doi: 10.1177/2048872614527010. Epub 2014 Mar 6.
PubMed 24604712Pape LA, Awais M, Woznicki EM, Suzuki T, Trimarchi S, Evangelista A, Myrmel T, Larsen M, Harris KM, Greason K, Di Eusanio M, Bossone E, Montgomery DG, Eagle KA, Nienaber CA, Isselbacher EM, O'Gara P. Presentation, Diagnosis, and Outcomes of Acute Aortic Dissection: 17-Year Trends From the International Registry of Acute Aortic Dissection. J Am Coll Cardiol. 2015 Jul 28;66(4):350-8. doi: 10.1016/j.jacc.2015.05.029.
PubMed 26205591Harris KM, Strauss CE, Eagle KA, Hirsch AT, Isselbacher EM, Tsai TT, Shiran H, Fattori R, Evangelista A, Cooper JV, Montgomery DG, Froehlich JB, Nienaber CA; International Registry of Acute Aortic Dissection (IRAD) Investigators. Correlates of delayed recognition and treatment of acute type A aortic dissection: the International Registry of Acute Aortic Dissection (IRAD). Circulation. 2011 Nov 1;124(18):1911-8. doi: 10.1161/CIRCULATIONAHA.110.006320. Epub 2011 Oct 3.
PubMed 21969019Evangelista A, Isselbacher EM, Bossone E, Gleason TG, Eusanio MD, Sechtem U, Ehrlich MP, Trimarchi S, Braverman AC, Myrmel T, Harris KM, Hutchinson S, O'Gara P, Suzuki T, Nienaber CA, Eagle KA; IRAD Investigators. Insights From the International Registry of Acute Aortic Dissection: A 20-Year Experience of Collaborative Clinical Research. Circulation. 2018 Apr 24;137(17):1846-1860. doi: 10.1161/CIRCULATIONAHA.117.031264.
PubMed 29685932Booher AM, Isselbacher EM, Nienaber CA, Trimarchi S, Evangelista A, Montgomery DG, Froehlich JB, Ehrlich MP, Oh JK, Januzzi JL, O'Gara P, Sundt TM, Harris KM, Bossone E, Pyeritz RE, Eagle KA; IRAD Investigators. The IRAD classification system for characterizing survival after aortic dissection. Am J Med. 2013 Aug;126(8):730.e19-24. doi: 10.1016/j.amjmed.2013.01.020.
PubMed 23885677
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Traumatic Aortic Dissection : Chain of Care and Pre-hospital Risk Factors, a Retrospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT04304443
- Acronym / sponsor ID
- FFDA / P/2019/453
- Conditions
- Aortic Dissection
- Keywords
- Aortic Dissection, Mortality, Treatment delay, Emergency, Pre-hospital phase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- 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
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 11 Mar 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients supported for an AAD between 2010-2019 in one of height hospitals centers participants.
Key inclusion criteria (3 listed)
- patients with age > 18 years
- patients with the diagnosis of non traumatic acute aortic dissection
- patients hospitalized in the university medical center
Key exclusion criteria (5 listed)
- 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
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
Mortality rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Results publication: PubMed 25668482Axelsson C, Karlsson T, Pande K, Wigertz K, Ortenwall P, Nordanstig J, Herlitz J. A description of the prehospital phase of aortic dissection in terms of early suspicion and treatment. Prehosp Disaster Med. 2015 Apr;30(2):155-62. doi: 10.1017/S1049023X15000060. Epub 2015 Feb 10.
- Results publication: PubMed 22062792Dixon M. Misdiagnosing aortic dissection: a fatal mistake. J Vasc Nurs. 2011 Dec;29(4):139-46. doi: 10.1016/j.jvn.2011.08.003.
- Results publication: PubMed 24604712Nazerian P, Giachino F, Vanni S, Veglio MG, Castelli M, Lison D, Bitossi L, Moiraghi C, Grifoni S, Morello F. Diagnostic performance of the aortic dissection detection risk score in patients with suspected acute aortic dissection. Eur Heart J Acute Cardiovasc Care. 2014 Dec;3(4):373-81. doi: 10.1177/2048872614527010. Epub 2014 Mar 6.
- Results publication: PubMed 26205591Pape LA, Awais M, Woznicki EM, Suzuki T, Trimarchi S, Evangelista A, Myrmel T, Larsen M, Harris KM, Greason K, Di Eusanio M, Bossone E, Montgomery DG, Eagle KA, Nienaber CA, Isselbacher EM, O'Gara P. Presentation, Diagnosis, and Outcomes of Acute Aortic Dissection: 17-Year Trends From the International Registry of Acute Aortic Dissection. J Am Coll Cardiol. 2015 Jul 28;66(4):350-8. doi: 10.1016/j.jacc.2015.05.029.
- Results publication: PubMed 21969019Harris KM, Strauss CE, Eagle KA, Hirsch AT, Isselbacher EM, Tsai TT, Shiran H, Fattori R, Evangelista A, Cooper JV, Montgomery DG, Froehlich JB, Nienaber CA; International Registry of Acute Aortic Dissection (IRAD) Investigators. Correlates of delayed recognition and treatment of acute type A aortic dissection: the International Registry of Acute Aortic Dissection (IRAD). Circulation. 2011 Nov 1;124(18):1911-8. doi: 10.1161/CIRCULATIONAHA.110.006320. Epub 2011 Oct 3.
- Results publication: PubMed 29685932Evangelista A, Isselbacher EM, Bossone E, Gleason TG, Eusanio MD, Sechtem U, Ehrlich MP, Trimarchi S, Braverman AC, Myrmel T, Harris KM, Hutchinson S, O'Gara P, Suzuki T, Nienaber CA, Eagle KA; IRAD Investigators. Insights From the International Registry of Acute Aortic Dissection: A 20-Year Experience of Collaborative Clinical Research. Circulation. 2018 Apr 24;137(17):1846-1860. doi: 10.1161/CIRCULATIONAHA.117.031264.
- Results publication: PubMed 23885677Booher AM, Isselbacher EM, Nienaber CA, Trimarchi S, Evangelista A, Montgomery DG, Froehlich JB, Ehrlich MP, Oh JK, Januzzi JL, O'Gara P, Sundt TM, Harris KM, Bossone E, Pyeritz RE, Eagle KA; IRAD Investigators. The IRAD classification system for characterizing survival after aortic dissection. Am J Med. 2013 Aug;126(8):730.e19-24. doi: 10.1016/j.amjmed.2013.01.020.
Related trials for Aortic Dissection
Not yet recruitingObservational study
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
Aortic Aneurysm and Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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.
Christian Daguerre, MD-student principal investigator
CHU de Besançon
Antoine Sigaux, MD study director
CHU de Besançon
Thibaut Desmettre, MD, PHD study chair
CHU de Besançon
2 sites 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 Universitaire de Besancon at 2 sites 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Daguerre, MD-student (+33 3 81 66 89 51, daguerrechristian@laposte.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 30 days). 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 NCT04304443, which also lists 7 linked publications.
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 23 Mar 2020.