Abdominal Aortic AneurysmNCT05197543
AAA Rupture Risk Assessment in COVID-19 Pandemic
An observational study of Abdominal Aortic Aneurysm and COVID-19, run by Masaryk University at 1 site in Czechia.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm, COVID-19
- What is being tested?
- Biomechanical rupture risk assessment
- How many people
- 102 participants
- Where
- 1 siteCzechia
- Study dates
- 12 Mar 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- presence of asymptomatic abdominal aortic aneurysm (AAA)
- regular CT angiography scans available
Who cannot join
- rupture of AAA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Abdominal Aortic Aneurysm, COVID-19
- Being tested
- Biomechanical rupture risk assessment
- Keywords
- Abdominal aortic Aneurysm, Biomechanics, Rupture risk, Predictability, COVID-19
- Medical subject headings
- Aortic Aneurysm, Abdominal, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomechanical rupture risk assessmentDiagnostic test
Also called Vascular wall stress assessment using finite element method
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 months
Secondary outcomes (1)
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
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start12 Mar 2020
- Primary completion17 Dec 2021
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- VSB - Technical University of Ostrava
- Responsible party
- Principal investigator, Luboš Kubíček, Masaryk University
- Investigators
- Robert Staffa, M.D., Ph.D., Study director, Masaryk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197543
- Sponsor's protocol ID
- BRRA19
- Status last verified
- Jan 2022
- First submitted
- 15 Jan 2022
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data are stored in standard patient documentation in study center, anonymized data can be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Rupture Risk Assessment in Management of Patients With Abdominal Aortic Aneurysm in COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05197543
- Acronym / sponsor ID
- BRRA19
- Conditions
- Abdominal Aortic Aneurysm, COVID-19
- Keywords
- Abdominal aortic Aneurysm, Biomechanics, Rupture risk, Predictability, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- VSB - Technical University of Ostrava
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- Mar 2022 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRRA group | – | Diagnostic Test: Biomechanical rupture risk assessmentRupture 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 |
| Maximal diameter group | – | –Rupture risk of asymptomatic AAAs in this group was estimated by a classical approach based on a maximal diameter. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- presence of asymptomatic abdominal aortic aneurysm (AAA)
- regular CT angiography scans available
Key exclusion criteria (1 listed)
- rupture of AAA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomechanical rupture risk assessmentAlso: Vascular wall stress assessment using finite element method3D 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. | Diagnostic test | BRRA group |
Primary outcome
Test the clinical applicability of the BRRA method
Time frame: 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
1 secondary outcome
Reduction of time required for AAA assessment
Time frame: 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: Undecided. All data are stored in standard patient documentation in study center, anonymized data can be shared on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Staffa, M.D., Ph.D. study director
Masaryk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and COVID-19, run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test the clinical applicability of the BRRA method (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.