Integrated Diagnostic Algorithm for Acute Aortic Syndromes

NCT04430400 | Completed

• 1 other identifier: 11005
• Study Type: observational
• Target: 3,023
• Locations: 5 countries
• Sites: 12

Brief Summary

Observational, prospective, multicentre, international, non-profit, investigator-driven, outcome and diagnostic accuracy study performed in Emergency Departments. The study will evaluate the performance of diagnostic algorithms integrating pre-test probability assessment with a risk score, focus cardiac ultrasound and D-dimer, to rule-in/out acute aortic syndromes. For each patient, the outcome will be established after review of hospital and 30-day follow-up data. In participating centers, an acute aortic syndrome will be considered to be ruled out without advanced imaging by a D-dimer level lower than 500 ng per milliliter, in patients with a low clinical pre-test probability assessed using the aortic dissection detection (ADD) risk score. Using outcome data, the study will primarily assess the accuracy and efficiency of this diagnostic rule-out protocol (prospective management study). The study will also evaluate the performance of alternative rule out strategies based on a different clinical score and on a D-dimer cutoff adjusted on patient's age.

Conditions

Acute Aortic Syndrome

Keywords

acute aortic syndrome; aortic dissection; d-dimer; echocardiography; emergency department; diagnosis

Outcome Measures

Primary Outcomes (3)

• Diagnostic performance of integrated diagnostic strategies for acute aortic syndromes

  The diagnostic performance of each diagnostic strategy will be assessed by computing sensitivity, specificity, negative/positive predictive values and negative/positive likelihood ratios with their 95% confident interval (95% CI).

  1 mont after the end of recruitment

• Failure rate of integrated diagnostic strategies for rule-out of acute aortic syndromes

  The failure rate (or false negative proportion) of each diagnostic strategy will be calculated as the number of patients with a final diagnosis of AAS divided by the number of patients satisfying rule-out criteria.

  1 mont after the end of recruitment

• Efficiency of integrated diagnostic strategies for rule-out of acute aortic syndromes

  The rule-out efficiency of each diagnostic strategy will be calculated as the number of patients satisfying the rule-out criteria divided by the number of all included patients.

  1 mont after the end of recruitment

Secondary Outcomes (1)

• Efficiency of integrated diagnostic strategies for rule-in of acute aortic syndromes

  1 month after the end of recruitment

Interventions

integrated diagnostic algorithm DIAGNOSTIC_TEST

Diagnostic management was as follows. An acute aortic syndrome will be considered to be ruled out without advanced aortic imaging, in clinically stable patients at low clinical pre-test probability (defined by ADD score ≤1) and a D-dimer level \<500 ng/mL FEU. The other patients will be subjected to advanced aortic imaging for conclusive diagnosis. Attending physicians will be allowed to derogate from protocol indications based on the clinical scenario and clinal gestalt, irrespective of patient's participation to the present study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be performed on adult outpatients evaluated for specified symptoms in the ED, in whom AASs are considered in differential diagnosis by the attending physician(s). Eligibility will be defined during or after medical evaluation in the ED and always before establishment of a final diagnosis. In each centre, patient recruitment will start after obtaining approval from the local Ethic Committee

You may qualify if:

• Presence of ≥1 of the following symptoms, dating ≤14 days: neck pain, truncal (thoracic/back/abdominal) pain, syncope, organ perfusion deficit (focal neurologic deficit, limb ischemia);
• AAS considered as meaningful diagnostic concern based on clinical judgement of the attending physician.

You may not qualify if:

• Age \<18 years;
• Evident alternative diagnoses to acute aortic syndromes (e.g. herpes zoster, skeletal pain);
• Primary trauma;
• History of previous acute aortic syndrome;
• Patient's refusal to participate.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (12)

Heart Institute, University of Sao Paolo

São Paulo, Brazil

Location

Charitè Universitätsmedizin

Berlin, Germany

Location

Universitätsklinikum Jena, Unit Zentrale Notaufnahme

Jena, Germany

Location

A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette, S.C. Medicina d'Urgenza U (MECAU)

Turin, Piedmont, 10126, Italy

Location

Emergency Department Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Azienda USL Toscana Centro, Medicina d'Urgenza e Dipartimento Emergenza e Area Critica

Empoli, Italy

Location

Ospedale Maggiore Policlinico, U.O.C Pronto Soccorso e Medicina D'Urgenza

Milan, Italy

Location

Ospedale Niguarda, Medicina d'Urgenza e Pronto Soccorso

Milan, Italy

Location

AOUP - Azienda Ospedaliera Università Pisana-Cisanello, Dipartimento di Emergenza

Pisa, Italy

Location

Policlinico Gemelli, Medicina d'Urgenza e Pronto Soccorso

Roma, Italy

Location

Permaisuri Bainun Hospital, Jalan Raja Ashman (Jalan Hospital)

Ipoh, Perak, 30400, Malaysia

Location

Universitätsspital Basel

Basel, Switzerland

Location

Related Publications (8)

• Nazerian P, Mueller C, Soeiro AM, Leidel BA, Salvadeo SAT, Giachino F, Vanni S, Grimm K, Oliveira MT Jr, Pivetta E, Lupia E, Grifoni S, Morello F; ADvISED Investigators. Diagnostic Accuracy of the Aortic Dissection Detection Risk Score Plus D-Dimer for Acute Aortic Syndromes: The ADvISED Prospective Multicenter Study. Circulation. 2018 Jan 16;137(3):250-258. doi: 10.1161/CIRCULATIONAHA.117.029457. Epub 2017 Oct 13.

  PMID: 29030346 RESULT

• Morello F, Mueller C, Soeiro AM, Leidel BA, Salvadeo SAT, Nazerian P; ADvISED Investigators. Response by Morello et al to Letters Regarding Article, "Diagnostic Accuracy of the Aortic Dissection Detection Risk Score Plus D-Dimer for Acute Aortic Syndromes: The ADvISED Prospective Multicenter Study". Circulation. 2018 Jul 24;138(4):448-449. doi: 10.1161/CIRCULATIONAHA.118.034861. No abstract available.

  PMID: 30571366 RESULT

• Nazerian P, Pivetta E, Veglia S, Cavigli E, Mueller C, de Matos Soeiro A, Leidel BA, Lupia E, Rutigliano C, Wussler D, Grifoni S, Morello F; ADvISED Investigators. Integrated Use of Conventional Chest Radiography Cannot Rule Out Acute Aortic Syndromes in Emergency Department Patients at Low Clinical Probability. Acad Emerg Med. 2019 Nov;26(11):1255-1265. doi: 10.1111/acem.13819. Epub 2019 Jul 22.

  PMID: 31220387 RESULT

• Nazerian P, Mueller C, Vanni S, Soeiro AM, Leidel BA, Cerini G, Lupia E, Palazzo A, Grifoni S, Morello F. Integration of transthoracic focused cardiac ultrasound in the diagnostic algorithm for suspected acute aortic syndromes. Eur Heart J. 2019 Jun 21;40(24):1952-1960. doi: 10.1093/eurheartj/ehz207.

  PMID: 31226214 RESULT

• Bima P, Pivetta E, Nazerian P, Toyofuku M, Gorla R, Bossone E, Erbel R, Lupia E, Morello F. Systematic Review of Aortic Dissection Detection Risk Score Plus D-dimer for Diagnostic Rule-out Of Suspected Acute Aortic Syndromes. Acad Emerg Med. 2020 Oct;27(10):1013-1027. doi: 10.1111/acem.13969. Epub 2020 Apr 21.

  PMID: 32187432 RESULT

• Morello F, Santoro M, Fargion AT, Grifoni S, Nazerian P. Diagnosis and management of acute aortic syndromes in the emergency department. Intern Emerg Med. 2021 Jan;16(1):171-181. doi: 10.1007/s11739-020-02354-8. Epub 2020 May 1.

  PMID: 32358680 RESULT

• Morello F, Bima P, Pivetta E, Santoro M, Catini E, Casanova B, Leidel BA, de Matos Soeiro A, Nestelberger T, Mueller C, Grifoni S, Lupia E, Nazerian P. Development and Validation of a Simplified Probability Assessment Score Integrated With Age-Adjusted d-Dimer for Diagnosis of Acute Aortic Syndromes. J Am Heart Assoc. 2021 Feb 2;10(3):e018425. doi: 10.1161/JAHA.120.018425. Epub 2021 Jan 21.

  PMID: 33474974 RESULT

• Morello F, Bima P, Castelli M, Capretti E, de Matos Soeiro A, Cipriano A, Costantino G, Vanni S, Leidel BA, Kaufmann BA, Osman A, Candelli M, Capsoni N, Behringer W, Capuano M, Ascione G, Leal TCAT, Ghiadoni L, Pivetta E, Grifoni S, Lupia E, Nazerian P; PROFUNDUS Study Investigators. Diagnosis of acute aortic syndromes with ultrasound and d-dimer: the PROFUNDUS study. Eur J Intern Med. 2024 Oct;128:94-103. doi: 10.1016/j.ejim.2024.05.029. Epub 2024 Jun 12.

  PMID: 38871565 DERIVED

MeSH Terms

Conditions

Acute Aortic Syndrome; Aortic Dissection; Emergencies; Disease

Condition Hierarchy (Ancestors)

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Dissection, Blood Vessel; Aneurysm; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fulvio Morello, MD, PhD

  Azienda Ospedaliero Universitaria Città della Salute e della Scienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director Emergency Department

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 12, 2020
• Study Start: December 1, 2019
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

MY (1); DE (2); BR (1); IT (7); CH (1)