Prediction of Aortic Dilation and Rupture in Different Predisposing Pathologies A Prospective Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Association of FD to aortic dilatation rate
Study Overview
Brief Summary
Aortic aneurysm is a very common incidental finding in the diagnostic imaging of the chest. It is especially common in middle aged men (up to 40 %). It is called as a silent killer, since it can lead to aortic dissection and rupture without pre-existing symptoms. Mortality of rupture can be up to 50 %. This is why it causes extensive human uncertainty and fear. Currently, there are no methods to identify the high risk patients. That leads to a practice where all patients are followed with repeated aortic imaging using expensive methods such as magnetic resonance imaging (MRI) and computed tomography.
There is data, that modern 4D flow MRI parameters well describe the intra-aortic flow conditions. This prospective clinical trial explore the value of 4D flow MRI parameters in the prediction of aortic dilatation and rupture. The trial consists of three subtrials in whitch the 4D flow MRI parameters are tested in clinical practice.
Detailed Description
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Purpose of the study The purpose of this study is to explore prognostic parameters for aortic dilation. More specifically it is to identify prognostic imaging parameters which could be used to identify patients at high risk for rapid aortic dilation and should be intensively followed by imaging methods.
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Subtrials
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Clinical study 1 The aim of the first phase of the study targets to identify 4D MRI flow parameters which are characteristic to dilated aorta and might be used to evaluate future prognosis in patients with aortic dilatation or predisposing factors.
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Clinical study 2 The second phase of the study aims to use identified flow parameters in clinical imaging follow up to find out which parameters predict aortic dilation in real life and thus could be used to select patients for more intensive imaging in future.
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Study 3 - Molecular pathology, histology and genetics of aorta The aim of this part of the study is to find out differences in molecular biology, histology, elasticity and genetics of the aorta in patients having predisposing factors for aortic dilation. Particularly, cellular factors influencing the formation of connective tissue and vascular smooth muscle layer will be studied.
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Methods
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Patient population All patients and healthy volunteers will give their written informed consent for the study. The Ethical Committee of Northern Savo hospital district has given approval for the trial.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aortic dilatation
- •scheduled for imaging follow up in Kuopio University Hospital
- •written informed concent
Exclusion Criteria
- •lack of co-operation
- •contraindications to MRI
Outcomes
Primary Outcomes
Association of FD to aortic dilatation rate
Time Frame: 5 years
4D flow MRI flow displacement value in correlation to aortic diameter in different time points
Association of WSS to aortic dilatation rate
Time Frame: 5 years
4D flow MRI wall shear stress value in correlation to aortic diameter in different time points
Secondary Outcomes
No secondary outcomes reported
Investigators
Marja Hedman
Professor
Kuopio University Hospital