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Prediction of Aortic Dilatation and Rupture (DilAo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05065996
Recruitment Status : Recruiting
First Posted : October 4, 2021
Last Update Posted : October 4, 2021
Sponsor:
Collaborators:
University of Eastern Finland
JAMK University Of Applied Sciences
Information provided by (Responsible Party):
Marja Hedman, Kuopio University Hospital

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.


Condition or disease Intervention/treatment
Aortic Rupture Diagnostic Test: Aortic MRI + 4D flow MRI

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prediction of Aortic Dilation and Rupture in Different Predisposing Pathologies A Prospective Clinical Study
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Group/Cohort Intervention/treatment
Different 4D flow MRI parameters in aortic dilatation and controls
Patients with aortic dilatation (n=20) scheduled for aortic MRI and healthy controls (n=20) without aortic dilatation. One time aortic MRI with 4D flow imaging.
Diagnostic Test: Aortic MRI + 4D flow MRI
Together with routine aortic MRI specific 4D flow MRI sequence will be done.

Value of aortic 4D flow MRI parameters to predict aortic dilatation in 5 years follow up
Patients with aortic dilatation (n=100) scheduled for aortic MRI follow up in Kuopio University Hospital. Aortic 4D flow MRI will be done yearly for 5 years and flow parameters predicting aortic dilatation will be analysed.
Diagnostic Test: Aortic MRI + 4D flow MRI
Together with routine aortic MRI specific 4D flow MRI sequence will be done.

Histology, molecular biology and genetics behind aortic dilatation
Patients scheduled for aortic operation (n=20+100) in Kuopio University Hospital. Aortic tissue samples and blood will be collected for analysis and compared to 4D flow MRI parameters. Control samples will be collected from healthy organ donors (n=5+5) operated in Kuopio University Hospital.
Diagnostic Test: Aortic MRI + 4D flow MRI
Together with routine aortic MRI specific 4D flow MRI sequence will be done.




Primary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. Association of WSS and FD to histology [ Time Frame: 2 years ]
    hematoxylin eosin, CD31, inflammatory cells of human aortic samples in correlation to WSS and FD

  2. Association of WSS and FD to genetics [ Time Frame: 2 years ]
    Gene screening from human blood samples of aortic patients



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
  • Patients with aortic dilatation scheduled for follow up in Kuopio University Hospital
  • Patients with aortic dilatation scheduled for aortic operation in Kuopio University Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065996


Contacts
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Contact: Saara Sillanmäki, PhD +358456334855 saara.sillanmaki@kuh.fi
Contact: Minna Husso, PhD +358447113918 minna.husso@kuh.fi

Locations
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Finland
Kuopio University Hospital Recruiting
Kuopio, Finland, 70029
Contact: Marja Hedman, Prof    +358505611768    marja.hedman@kuh.fi   
Contact: Saara Sillanmäki, PhD    +358456334855    saara.sillanmaki@kuh.fi   
Sub-Investigator: Annastiina Husso, MD, PhD         
Sub-Investigator: Antti Valtola, MD,PhD         
Sub-Investigator: Tarmo Korpela, MB         
Sub-Investigator: Johanna P Laakkonen, PhD         
Sub-Investigator: Miika Kiema, BSc         
Sub-Investigator: Petteri Kauhanen, MD,PhD         
Sub-Investigator: Petri Saari, MD,PhD         
Sub-Investigator: Minna Husso, PhD         
Sub-Investigator: Elias Ylä-herttuala, PhD         
Sub-Investigator: Iida Viitala, MD         
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland
JAMK University Of Applied Sciences
Investigators
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Principal Investigator: Marja Hedman, Prof Kuopio University Hospital
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Responsible Party: Marja Hedman, Professor, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT05065996    
Other Study ID Numbers: 5063566
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: only anonymous imaging data will be send to JAMK university of applied sciences for mathematical modelling of aorta

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marja Hedman, Kuopio University Hospital:
aortic dilatation
aortic aneurysm
4D flow MRI
aortic rupture
Additional relevant MeSH terms:
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Aortic Rupture
Rupture
Wounds and Injuries
Aneurysm, Ruptured
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Aortic Diseases