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Integrated Diagnostic Algorithm for Acute Aortic Syndromes

NCT04430400 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3023

Last updated 2023-02-09

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

integrated diagnostic algorithm

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.

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Principal Investigators

  • Fulvio Morello, MD, PhD · Azienda Ospedaliero Universitaria Città della Salute e della Scienza

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2023-01-04
Completion
2023-01-04

Countries

  • Brazil
  • Germany
  • Italy
  • Malaysia
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04430400 on ClinicalTrials.gov