Aortic AneurysmNCT02800876
Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk
An observational study of Aortic Aneurysm, run by University of Zurich at 1 site in Switzerland.
Trial summary
Retrospective study to evaluate the impact of computational wall stress analysis based on computed tomography (CT) of ruptured and not-ruptured aortic aneurysms as an additional predictor for rupture with dedicated software. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- CT-acquisition
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to Dec 2017
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known aortic aneurysms, who underwent clinical indicated CT during a time period from 01/2004-12/2013
Who may be able to join
- Clinical indicated CT data from patients with known aortic aneurysms.
- Clinical indication was:
- Follow up CT examination by known aortic aneurysm
- Patient with known aortic aneurysm with new acute clinical symptoms
- Patients with clinical suspicion of aortic aneurysm
Who cannot join
- known exclusion criteria for CT examination as known allergy to iodine or contrast media
- known pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Thi Dan Linh Nguyen-Kim, Dr. med., 0041442552900, thidanlinh.nguyen@usz.ch
About this study
Official title: Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk by Computational Finite Element Analysis With Dedicated Software
Retrospective study to evaluate the impact of computational wall stress analysis based on computed tomography (CT) of ruptured and not-ruptured aortic aneurysms as an additional predictor for rupture with dedicated software.
Read the detailed description
In patients with known aortic aneurysm who received clinically indicated CT during a time period from 01/2004-12/2013 the CT data was evaluated with dedicated software, A4clinics, VASCOPS GmbH, Graz, Austria. The following parameters will be evaluated: exterior and luminal diameter, intraluminal thrombus (ILT) thickness, vessel-, luminal- and intraluminal thrombus volume, peak wall stress (PWS), peak wall rupture risk (PWRR), von Mises-stress and rupture risk-index in the ILT.
- Conditions
- Aortic Aneurysm
- Being tested
- CT-acquisition
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-acquisitionOther
| Study group | Role | What they receive |
|---|---|---|
| asymptomatic not ruptured aneurysm | Patients with asymptomatic not ruptured aortic aneurysms greater than 3 cm who received a clinical indicated CT Receives: Other: CT-acquisition | |
| symptomatic not ruptured aneurysm | Patients with symptomatic aortic aneurysms greater than 3 cm who received a clinical indicated CT Receives: Other: CT-acquisition | |
| symptomatic ruptured aneurysm | Patients with symptomatic ruptured aortic aneurysms greater than 3 cm who received a clinical indicated CT Receives: Other: CT-acquisition | |
| patients with small aneurysms | Patients with small aortic aneurysms approximately 5.5 cm, ruptured and not ruptured, who received a clinical indicated CT Receives: Other: CT-acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
To calculated the rupture risk equivalent diameter (RRED) of the aortic aneurysm and rupture risk-index in the intraluminal thrombus within the aortic aneurysm.
By using the finite analysis from the CT data the peak wall stress (PWS), the peak wall rupture (PWRR) and the mises stress within the aortic aneurysm depending on the diameter and volume of the aortic aneurysm and of the intraluminal thrombus will be measured.
Measured: CT Data from 01/2004-12/2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thi Dan Linh Nguyen-Kim, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800876
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0156
- Status last verified
- Jun 2016
- First submitted
- 8 Jun 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk by Computational Finite Element Analysis With Dedicated Software
- ClinicalTrials.gov ID
- NCT02800876
- Acronym / sponsor ID
- KEK-ZH-Nr. 2015-0156
- Conditions
- Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- 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.
Retrospective study to evaluate the impact of computational wall stress analysis based on computed tomography (CT) of ruptured and not-ruptured aortic aneurysms as an additional predictor for rupture with dedicated software.
Detailed description
In patients with known aortic aneurysm who received clinically indicated CT during a time period from 01/2004-12/2013 the CT data was evaluated with dedicated software, A4clinics, VASCOPS GmbH, Graz, Austria. The following parameters will be evaluated: exterior and luminal diameter, intraluminal thrombus (ILT) thickness, vessel-, luminal- and intraluminal thrombus volume, peak wall stress (PWS), peak wall rupture risk (PWRR), von Mises-stress and rupture risk-index in the ILT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| asymptomatic not ruptured aneurysm | – | Other: CT-acquisitionPatients with asymptomatic not ruptured aortic aneurysms greater than 3 cm who received a clinical indicated CT |
| symptomatic not ruptured aneurysm | – | Other: CT-acquisitionPatients with symptomatic aortic aneurysms greater than 3 cm who received a clinical indicated CT |
| symptomatic ruptured aneurysm | – | Other: CT-acquisitionPatients with symptomatic ruptured aortic aneurysms greater than 3 cm who received a clinical indicated CT |
| patients with small aneurysms | – | Other: CT-acquisitionPatients with small aortic aneurysms approximately 5.5 cm, ruptured and not ruptured, who received a clinical indicated CT |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known aortic aneurysms, who underwent clinical indicated CT during a time period from 01/2004-12/2013
Key inclusion criteria (5 listed)
- Clinical indicated CT data from patients with known aortic aneurysms.
- Follow up CT examination by known aortic aneurysm
- Patient with known aortic aneurysm with new acute clinical symptoms
- Patients with clinical suspicion of aortic aneurysm
Key exclusion criteria (2 listed)
- known exclusion criteria for CT examination as known allergy to iodine or contrast media
- known pregnancy
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 |
|---|---|---|
| CT-acquisition | Other | asymptomatic not ruptured aneurysm, patients with small aneurysms, symptomatic not ruptured aneurysm, symptomatic ruptured aneurysm |
Primary outcome
To calculated the rupture risk equivalent diameter (RRED) of the aortic aneurysm and rupture risk-index in the intraluminal thrombus within the aortic aneurysm.
Time frame: CT Data from 01/2004-12/2013
By using the finite analysis from the CT data the peak wall stress (PWS), the peak wall rupture (PWRR) and the mises stress within the aortic aneurysm depending on the diameter and volume of the aortic aneurysm and of the intraluminal thrombus will be measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
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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.
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 Aortic Aneurysm, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 2 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 15 Jun 2016. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To calculated the rupture risk equivalent diameter (RRED) of the aortic aneurysm and rupture risk-index in the intraluminal thrombus within the aortic aneurysm. (time frame: CT Data from 01/2004-12/2013). 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 15 Jun 2016.