Prediction of Aortic Dilatation and Rupture

NCT05065996 | Completed

• 1 other identifier: 5063566
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Rupture

Keywords

aortic dilatation; aortic aneurysm; 4D flow MRI; aortic rupture

Outcome Measures

Primary Outcomes (2)

• Association of WSS to aortic dilatation rate

  4D flow MRI wall shear stress value in correlation to aortic diameter in different time points

  5 years

• Association of FD to aortic dilatation rate

  4D flow MRI flow displacement value in correlation to aortic diameter in different time points

  5 years

Other Outcomes (2)

• Association of WSS and FD to histology

  2 years

• Association of WSS and FD to genetics

  2 years

Study Arms (3)

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

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

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

Interventions

Aortic MRI + 4D flow MRI DIAGNOSTIC_TEST

Together with routine aortic MRI specific 4D flow MRI sequence will be done.

Different 4D flow MRI parameters in aortic dilatation and controls; Histology, molecular biology and genetics behind aortic dilatation; Value of aortic 4D flow MRI parameters to predict aortic dilatation in 5 years follow up

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• aortic dilatation
• scheduled for imaging follow up in Kuopio University Hospital
• written informed concent

You may not qualify if:

• lack of co-operation
• contraindications to MRI

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator
• JAMK University Of Applied Sciences: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, 70029, Finland

Location

Related Publications (1)

• Kiljander T, Kauhanen P, Sillanmaki S, Lottonen-Raikaslehto L, Husso M, Yla-Herttuala E, Saari P, Kokkonen J, Laukkanen J, Mustonen P, Hedman M. Repaired coarctation of the aorta does not affect four-dimensional flow metrics in bicuspid aortic valve disease. Interdiscip Cardiovasc Thorac Surg. 2024 May 2;38(5):ivae086. doi: 10.1093/icvts/ivae086.

  PMID: 38704861 DERIVED

MeSH Terms

Conditions

Aortic Rupture; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm, Ruptured; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Rupture; Wounds and Injuries

Study Officials

• Marja Hedman, Prof

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 4, 2021
• Study Start: January 1, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)