Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk
1 other identifier
observational
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 15, 2016
June 1, 2016
11 months
June 8, 2016
June 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
CT Data from 01/2004-12/2013
Study Arms (4)
asymptomatic not ruptured aneurysm
Patients with asymptomatic not ruptured aortic aneurysms greater than 3 cm who received a clinical indicated CT
symptomatic not ruptured aneurysm
Patients with symptomatic aortic aneurysms greater than 3 cm who received a clinical indicated CT
symptomatic ruptured aneurysm
Patients with symptomatic ruptured aortic aneurysms greater than 3 cm who received a clinical indicated CT
patients with small aneurysms
Patients with small aortic aneurysms approximately 5.5 cm, ruptured and not ruptured, who received a clinical indicated CT
Interventions
Eligibility Criteria
Patients with known aortic aneurysms, who underwent clinical indicated CT during a time period from 01/2004-12/2013
You may qualify if:
- 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
You may not qualify if:
- known pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med.
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 15, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
June 15, 2016
Record last verified: 2016-06