Clinical trial NCT03138434: Advanced MRI in AAA
Official title: Advanced MRI in AAA
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal Aortic Aneurysm
4D flow MRI
DCE-MRI
T1 and T2 mapping
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with an abdominal aortic aneurysms who are patients at the department of vascular surgery of the Academic Medical Center.

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Wall shear stress (WSS)
timeFrame: Time of MRI scan
measure: Kinetic transport constant (Ktrans)
timeFrame: Time of MRI scan
measure: T1 relaxation time
timeFrame: Time of MRI scan
measure: T2 relaxation time
timeFrame: Time of MRI scan
Secondary outcomes:
measure: Peak flow velocity inside the aneurysm
timeFrame: Time of MRI scan
measure: Location of peak wall shear stress
timeFrame: Time of MRI scan
measure: Flow velocity at aneurysm entrance
timeFrame: Time of MRI scan
measure: Flow patterns
timeFrame: Time of MRI scan
measure: Oscillatory shear index
timeFrame: Time of MRI scan
measure: Reverse reflux rate constant (kep)
timeFrame: Time of MRI scan
measure: Area under the curve of contrast uptake
timeFrame: Time of MRI scan
measure: Peak enhancement ratio
timeFrame: Time of MRI scan
measure: Wash-in slope
timeFrame: Time of MRI scan
measure: Time to peak (TTP)
timeFrame: Time of MRI scan
measure: Mean transit time (MTT)
timeFrame: Time of MRI scan
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Department of Vascular Surgery
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Ron Balm, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: