AAA Rupture Risk Assessment in COVID-19 Pandemic

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

AAA Rupture Risk Assessment in COVID-19 Pandemic

Official Title

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

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.

Study Type

Observational

Primary Outcome

Test the clinical applicability of the BRRA method

Secondary Outcome

 Reduction of time required for AAA assessment

Condition

Abdominal Aortic Aneurysm

Intervention

Biomechanical rupture risk assessment

Study Arms / Comparison Groups

 BRRA group
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

102

Start Date

March 12, 2020

Completion Date

March 2022

Primary Completion Date

December 17, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  presence of asymptomatic abdominal aortic aneurysm (AAA)

          -  regular CT angiography scans available

        Exclusion Criteria:

          -  rupture of AAA

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Robert Staffa, M.D., Ph.D., ,

Location Countries

Czechia

Location Countries

Czechia

Administrative Informations

NCT ID

NCT05197543

Organization ID

BRRA19

Responsible Party

Principal Investigator

Study Sponsor

Masaryk University

Collaborators

 VSB - Technical University of Ostrava

Study Sponsor

Robert Staffa, M.D., Ph.D., Study Director, Masaryk University

Verification Date

January 2022