NCT04430400: PROFUNDUS

Integrated Diagnostic Algorithm for Acute Aortic Syndromes

Completed Last updated 9 February 2023

What this trial tests

trial testing integrated diagnostic algorithm in Acute Aortic Syndrome in 3,023 participants. Completed in 4 January 2023.

Timeline

1 December 2019

Primary endpoint
4 January 2023

4 January 2023

Quick facts

Lead sponsor	Azienda Ospedaliero-Universitaria Careggi
Status	Completed
Study type	OBSERVATIONAL
Enrollment	3,023
Start date	1 December 2019
Primary completion	4 January 2023
Estimated completion	4 January 2023
Sites	12 locations across Italy, Malaysia, Germany, Switzerland, Brazil

Drugs / interventions tested

• integrated diagnostic algorithm

Conditions studied

• Acute Aortic Syndrome — all drugs for Acute Aortic Syndrome →

Sponsor

Azienda Ospedaliero-Universitaria Careggi — full company profile →

Who can join

18 and older, any sex, with Acute Aortic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Diagnosis of acute aortic syndromes with ultrasound and d-dimer: the PROFUNDUS study.
   Morello F, Bima P, Castelli M, Capretti E, et al · · 2024 · cited 12× · PMID 38871565 · DOI 10.1016/j.ejim.2024.05.029