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NCT05197543 Clinical Trial

AAA Rupture Risk Assessment in COVID-19 Pandemic

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05197543
Other study ID # BRRA19
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 12, 2020
Est. completion date March 2022

Study information
Verified date January 2022
Source Masaryk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 102
Est. completion date March 2022
Est. primary completion date December 17, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - presence of asymptomatic abdominal aortic aneurysm (AAA) - regular CT angiography scans available Exclusion Criteria: - rupture of AAA

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Biomechanical rupture risk assessment
3D 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.

Locations
Country Name City State
Czechia St. Anne´s University Hospital in Brno Brno

Sponsors (2)
Lead Sponsor Collaborator
Masaryk University VSB - Technical University of Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Test the clinical applicability of the BRRA method Identify the number of number of false positive and false negative cases assessed by BRRA method according to clinical data and compare these data to control group where the decision making process was based only on maximal diameter of AAA 21 months
Secondary Reduction of time required for AAA assessment To investigate the feasibility of cooperation between the biomechanical and medical teams in a modified AAA management workflow leading to reduced time required for an AAA assessment 21 months
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