Advanced MRI in AAA

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Advanced MRI in AAA

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03138434
• Other study ID #: NL56823.018.16
• Status: Terminated
• Start date: April 12, 2017
• Est. completion date: May 29, 2019

Study information

• Verified date: July 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to determine whether advanced MRI sequences can provide robust and clinically relevant information about abdominal aortic aneurysms (AAAs). The MRI sequences will study outcomes related to blood flow inside AAA, microvasculature of the AAA vessel wall and intraluminal thrombus inside AAA.

Robustness of these MRI sequences will be determined with testing of feasibility and reproducibility. Clinical relevance will be assessed by studying the association between the primary outcomes and disease severity. Disease severity will be expressed by AAA diameter.

It is our hypothesis that these parameters are significantly related to disease severity and may therefore be future markers of disease progression.

Description:

This prospective study evaluates the feasibility, reproducibility and clinical relevance of MRI sequences in adults with an abdominal aortic aneurysm (AAA).

The MRI sequences and their primary outcomes are:

• Four-dimensional (4D) flow MRI and wall shear stress (WSS)

• Dynamic Contrast-Enhanced (DCE) MRI and kinetic transport constant (Ktrans)

• T1 and T2 mapping (T1 and T2 relaxation times)

Feasibility is tested by the production of high-quality images that enable calculation of the primary outcomes. Reproducibility is tested by calculating interscan, intra- and interobserver variability. Clinical relevance is tested by assessing the association between primary outcomes and disease severity which is expressed by AAA diameter

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (= 18 years of age)

• Abdominal aortic aneurysm with a maximal aneurysm diameter of at least 30 mm

Exclusion Criteria:

• Contra-indications for MRI

• Severely reduced renal function (eGFR < 30)

• Previous allergic reaction to intravenous contrast agents

• Suprarenal AAA

• Pararenal AAA

• Previous aneurysm repair

• Inflammatory aneurysm

• Mycotic or other infectious aneurysm

• Vasculitis

• Connective tissue disease

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
Netherlands	Department of Vascular Surgery	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Ron Balm

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wall shear stress (WSS)	Primary outcome of 4D flow MRI	Time of MRI scan
Primary	Kinetic transport constant (Ktrans)	Primary outcome of DCE-MRI	Time of MRI scan
Primary	T1 relaxation time	Primary outcome of T1 mapping	Time of MRI scan
Primary	T2 relaxation time	Primary outcome of T2 mapping	Time of MRI scan
Secondary	Peak flow velocity inside the aneurysm	Secondary outcome of 4D flow MRI	Time of MRI scan
Secondary	Location of peak wall shear stress	Secondary outcome of 4D flow MRI	Time of MRI scan
Secondary	Flow velocity at aneurysm entrance	Secondary outcome of 4D flow MRI	Time of MRI scan
Secondary	Flow patterns	Secondary outcome of 4D flow MRI	Time of MRI scan
Secondary	Oscillatory shear index	Secondary outcome of 4D flow MRI	Time of MRI scan
Secondary	Reverse reflux rate constant (kep)	Secondary outcome of DCE-MRI	Time of MRI scan
Secondary	Area under the curve of contrast uptake	Secondary outcome of DCE-MRI	Time of MRI scan
Secondary	Peak enhancement ratio	Secondary outcome of DCE-MRI	Time of MRI scan
Secondary	Wash-in slope	Secondary outcome of DCE-MRI	Time of MRI scan
Secondary	Time to peak (TTP)	Secondary outcome of DCE-MRI	Time of MRI scan
Secondary	Mean transit time (MTT)	Secondary outcome of DCE-MRI	Time of MRI scan