Clinical trial NCT05976711: New MRI Techniques for Diagnosis and Treatment of Patients With Abdominal Aortic Aneurysms
Official title: Gamechanger: Development of MRI Based Endovascular Procedures for Vascular Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysm Without Rupture
Keywords: Abdominal Aortic Aneurysm
Magnetic Resonance Imaging
4D flow MRI
DCE MRI
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Brightfish
name: Nano4Imaging GmbH
First posted: 2023-08-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an AAA from the Amsterdam UMC

Brief summary: An abdominal aortic aneurysm (AAA) is a pathological dilatation of the aorta in the belly which can rupture leading to bleeding within the belly. To prevent rupture elective surgery can be performed. Endovascular repair (EVAR) is a surgical intervention whereby a stent is inserted into the AAA to prevent it from further growth and rupture.

Standard AAA management has several drawbacks. To start: maximum AAA diameter is used to determine upon timing of elective repair but is imprecise in predicting the risk of rupture resulting in an unmet clinical need. Secondly, EVAR outcome and complication occurrence remain unpredictable due to poor prediction ability of computed tomography (CT) and ultrasound (US) utilised in the follow-up protocol. Lastly, patients and physicians are being repeatedly exposed to cumulative radiation toxicity. All these drawbacks could be solved by trading the standard imaging modalities by magnetic resonance imaging (MRI). Within the MARVY, advanced MRI techniques are used to find out if standard imaging techniques could be replaced by MRI in three phases of the AAA management (surveillance, surgery planning and post-operative follow-up). The two most important MRI techniques that will be used are 4D flow MRI and dynamic contrast enhanced (DCE) MRI which give respectively information about the blood flow within the AAA and perfusion of the aortic wall.


Eligibility criteria: Inclusion Criteria:

* diagnosed with AAA
* provision of written informed consent

Inclusion Criteria for surveillance part:

* maximum AAA diameter between 3-5 cm
* not scheduled for aneurysm repair at the time of inclusion

Inclusion Criteria for planning part:

* planned for elective EVAR

Inclusion Criteria for follow-up part:

* ten complication free years after EVAR or sac regression after EVAR; or
* type I endoleak after EVAR; or
* type II endoleak after EVAR;

Exclusion Criteria:

* Supra- or pararenal AAA
* Inflammatory, infectious or mycotic AAA
* Vasculitis and connective tissue disease
* Patients that underwent open surgical repair for their AAA
* Patients with ruptured AAAs
* Patients that previously presented with allergic reactions to intravenous contrast agents

Exclusion Criteria for surveillance part:

* previous AAA repair
* severely reduced renal function
* previous allergic reactions to intravenous contrast agents

Exclusion Criteria for planning part:

* previous AAA repair

Exclusion Criteria for follow-up part:

* severely reduced renal function
* previous allergic reactions to intravenous contrast agents

Primary outcomes:
measure: Surveillance: correlation between growth rate and MRI derived parameters
timeFrame: 1 year
measure: EVAR planning: correlation between morphological parameters measured based on MRA and CTA
timeFrame: half year
measure: EVAR follow up: difference in MRI parameters between patients with endoleaks and without
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
References: