Clinical Trials Directory

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UnknownNCT05197543

AAA Rupture Risk Assessment in COVID-19 Pandemic

Biomechanical Rupture Risk Assessment in Management of Patients With Abdominal Aortic Aneurysm in COVID-19 Pandemic

Status
Unknown
Phase
Study type
Observational
Enrollment
102 (actual)
Sponsor
Masaryk University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

The acute phase of the COVID-19 pandemic requires a redefinition of healthcare system to increase the number of available intensive care units for COVID-19 patients. This leads to the postponing of elective surgeries including the treatment of abdominal aortic aneurysm (AAA). The probabilistic rupture risk index (PRRI) recently showed its advantage over the diameter criterion in AAA rupture risk assessment. Its major improvement is in increased specificity and yet has the same sensitivity as the maximal diameter criterion. The objective of this study was to test the clinical applicability of the PRRI diagnostic method in a quasi-prospective observational patient cohort study.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBiomechanical rupture risk assessment3D computational model is created from CT angiographic images available during standard AAA diagnostic process. Vascular wall stress is assessed based on the 3D model using Finite element method to identify highly stressed parts of AAA and results are compared to populational wall strength information (gathered from previous large histological study), thus rupture risk (stress/strength ratio) of each particular AAA is estimated. Other relevant factors such as gender, blood pressure, presence of intraluminal thrombus etc. are used during the calculation as well.

Timeline

Start date
2020-03-12
Primary completion
2021-12-17
Completion
2022-03-01
First posted
2022-01-19
Last updated
2022-01-25

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT05197543. Inclusion in this directory is not an endorsement.