AAA Rupture Risk Assessment in COVID-19 Pandemic

• Conditions: Abdominal Aortic Aneurysm; COVID-19
• Interventions: Diagnostic Test: Biomechanical rupture risk assessment

• Registration Number: NCT05197543
• Lead Sponsor: Masaryk University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-12
• Primary Completion: 2021-12-17
• Status Verified: 2022-01
• Study First Submitted: 2022-01-15
• Study First Submitted QC: 2022-01-15
• Study First Posted: 2022-01-19
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-25
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• presence of asymptomatic abdominal aortic aneurysm (AAA)
• regular CT angiography scans available

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Exclusion Criteria

• rupture of AAA

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BRRA group	Biomechanical rupture risk assessment	Rupture risk of asymptomatic AAAs in this group was estimated using Biomechanical rupture rist assessment (BRRA). BRRA considers an AAA as a pressure vessel and estimates its risk of rupture by comparing its wall stress to wall strength

Primary Outcome Measures

Name	Time	Method
Test the clinical applicability of the BRRA method	21 months	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

Secondary Outcome Measures

Name	Time	Method
Reduction of time required for AAA assessment	21 months	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

Trial Locations

Locations (1)

St. Anne´s University Hospital in Brno; 🇨🇿 Brno, Czechia