Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk

Sponsor

University of Zurich (Other)

Overall Status

Unknown status

CT.gov ID

NCT02800876

Collaborator

(none)

150

Enrollment

Location

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm	Other: CT-acquisition

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

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk by Computational Finite Element Analysis With Dedicated Software

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
asymptomatic not ruptured aneurysm Patients with asymptomatic not ruptured aortic aneurysms greater than 3 cm who received a clinical indicated CT	Other: CT-acquisition
symptomatic not ruptured aneurysm Patients with symptomatic aortic aneurysms greater than 3 cm who received a clinical indicated CT	Other: CT-acquisition
symptomatic ruptured aneurysm Patients with symptomatic ruptured aortic aneurysms greater than 3 cm who received a clinical indicated CT	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	Other: CT-acquisition

Outcome Measures

Primary Outcome Measures

To calculated the rupture risk equivalent diameter (RRED) of the aortic aneurysm and rupture risk-index in the intraluminal thrombus within the aortic aneurysm. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

known exclusion criteria for CT examination as known allergy to iodine or contrast media
known pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zurich		Switzerland	8091

Sponsors and Collaborators

University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thi Dan Linh Nguyen-Kim, Dr. med., University of Zurich

ClinicalTrials.gov Identifier:

NCT02800876

Other Study ID Numbers:

KEK-ZH-Nr. 2015-0156

First Posted:

Jun 15, 2016

Last Update Posted:

Jun 15, 2016

Last Verified:

Jun 1, 2016

Additional relevant MeSH terms:

Aneurysm

Aortic Aneurysm

Rupture

Study Results

No Results Posted as of Jun 15, 2016