AAA Rupture Risk Assessment in COVID-19 Pandemic

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Abdominal Aortic Aneurysm
• Intervention / Treatment: Diagnostic test: Biomechanical rupture risk assessment

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 65691
    • St. Anne´s University Hospital in Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with asymptomatic AAA during the COVID-19 pandemic period. During this period an elective surgeries had to be posponed and there was a need for auxiliary diagnostic method able to identify AAAs with high risk of rupture.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• rupture of AAA

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BRRA group; 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	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.; Other Names: Vascular wall stress assessment using finite element method
Maximal diameter group; Rupture risk of asymptomatic AAAs in this group was estimated by a classical approach based on a maximal diameter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Masaryk University
• Collaborators: VSB - Technical University of Ostrava
• Investigators: Study Director: Robert Staffa, M.D., Ph.D., Masaryk University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): December 17, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 15, 2022
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Biomechanics; Predictability; Abdominal aortic Aneurysm; Rupture risk
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Wounds and Injuries; Aortic Diseases; COVID-19; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: BRRA19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All data are stored in standard patient documentation in study center, anonymized data can be shared on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No