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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• COVID-19
• Rupture

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