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Comparison of elastic properties between the aortic root and the tubular ascending aorta in patients with an aortic aneurysm


- candidate number14907
- NTR NumberNTR4003
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-mei-2013
- Secondary IDs2013/143 Mec UZ Brussel
- Public TitleComparison of elastic properties between the aortic root and the tubular ascending aorta in patients with an aortic aneurysm
- Scientific Title*ULTIMATA@BME: Comparison of elastic properties between the aortic root and the tubular ascending aorta in patients with an aortic aneurysm *:(Ultrasonic Imaging and mechanical testing of thoracic aneurysms @ Brussels, Maastricht & Eindhoven)
- ACRONYMULTIMATA@BME
- hypothesisThe aim of the study is to analyse aortic distensibility by the use of 3D live echocardiographic images (speckle tracking)of the aortic root and ascending aorta and perform mechanical testing on resected aortic specimens for validation purposes.
- Healt Condition(s) or Problem(s) studiedEchocardiography, Biaxial tensile testing, Aneurysmal ascending aorta, Aortic distensibility, Aortic root, Elastic behaviour
- Inclusion criteriaAdult patients scheduled for surgical repair of a dilated ascending aorta and/or aortic root and controls, scheduled for non-aortic surgery. Bicuspid aortic valves are not a contra-indication.
- Exclusion criteriaMinors or incapacitated adults will not be included in the study. Subjects that do not want to give their informed consent will not be included.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 31-mei-2013
- planned closingdate31-mei-2014
- Target number of participants40
- Interventions1. After induction of general anesthesia, immediately prior to the cardiac operation, a transesophageal echocardiography is performed in line with central aortic pressure, as measured through an already present aortic root venting needle. The encrypted data (all patient information removed) will be transferred to the Technical University of Eindhoven (dept. of Biomedical Engineering) for offline image analysis.
2. The resected aneurysmal wall will be transferred to the Technical University Eindhoven (dept. of Biomedical Engineering) for biaxial tensile testing. A piece of the wall will also be subjected to histological analysis in order to quantify the extent of medial changes according to the classification of Schlatmann and Becker.
- Primary outcomeCharacterisation of elastic behaviour of the aneurysmal ascending aorta.
- Secondary outcomeCompare the elastic behaviour of the tubular ascending aorta with the aortic root.
- Timepoints1.After induction of general anesthesia, immediately prior to the cardiac operation, a transesophageal echocardiography is performed in line with central aortic pressure, as measured through an already present aortic root venting needle.
2. The resected aneurysmal wall will be transferred to the Technical University Eindhoven (dept. of Biomedical Engineering) for biaxial tensile testing. A piece of the wall will also be subjected to histological analysis in order to quantify the extent of medial changes according to the classification of Schlatmann and Becker.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Veerle Mossevelde, van
- CONTACT for SCIENTIFIC QUERIES Jan Nijs
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Universitair Ziekenhuis Brussel
- PublicationsN/A
- Brief summaryThe goal of this study is to investigate the elastic behaviour of the aneurysmal ascending aorta. Therefore, elastic parameters derived from echocardiographic images of the ascending aorta and pressure measurements will be analyzed. The resected aortic aneurysmal tissue will be analysed by biaxial tensile testing to quantify its elasticbehaviour.
- Main changes (audit trail)
- RECORD21-mei-2013 - 29-mei-2013


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