AAA Rupture Risk Assessment in COVID-19 Pandemic

NCT05197543 | Unknown

• 1 other identifier: BRRA19
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm; COVID-19

Keywords

Abdominal aortic Aneurysm; Biomechanics; Rupture risk; Predictability; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction of time required for AAA assessment

  21 months

Study Arms (2)

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

Maximal diameter group

Rupture risk of asymptomatic AAAs in this group was estimated by a classical approach based on a maximal diameter.

Interventions

Biomechanical rupture risk assessment DIAGNOSTIC_TEST

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.

Also known as: Vascular wall stress assessment using finite element method

BRRA group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• rupture of AAA

Sponsors & Collaborators

• Masaryk University: lead
• VSB - Technical University of Ostrava: collaborator

Study Sites (1)

St. Anne´s University Hospital in Brno

Brno, 65691, Czechia

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; COVID-19

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert Staffa, M.D., Ph.D.

  Masaryk University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invastigator

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: January 19, 2022
• Study Start: March 12, 2020
• Primary Completion: December 17, 2021
• Study Completion: March 1, 2022
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

CZ (1)