Clinical trial NCT04304443: Pre-hospital Management of Aortic Dissection
Official title: Non Traumatic Aortic Dissection : Chain of Care and Pre-hospital Risk Factors, a Retrospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Keywords: Aortic Dissection
Mortality
Treatment delay
Emergency
Pre-hospital phase
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Hopital Nord Franche-Comte
name: Centre Hospitalier de Lons Le Saunier
name: Centre hospitalier de Vesoul
name: Centre hospitalier de Pontarlier
name: Centre hospitalier de Gray
name: Centre hospitalier de Dole
name: Centre Hospitalier de Saint-Claude
First posted: 2020-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients supported for an AAD between 2010-2019 in one of height hospitals centers participants.

Brief 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). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
affiliation: CHU de Besançon
name: Christian Daguerre, MD-student
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Besançon
name: Antoine Sigaux, MD
role: STUDY_DIRECTOR
affiliation: CHU de Besançon
name: Thibaut Desmettre, MD, PHD
role: STUDY_CHAIR
References:
citation: 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.
citation: Dixon M. Misdiagnosing aortic dissection: a fatal mistake. J Vasc Nurs. 2011 Dec;29(4):139-46. doi: 10.1016/j.jvn.2011.08.003.
citation: Nazerian 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.
citation: Pape 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.
citation: Harris 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.
citation: Evangelista 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.
citation: Booher 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.