New MRI Techniques for Diagnosis and Treatment of Patients With Abdominal Aortic Aneurysms (NCT05976711) | Clinical Trial Compass
CompletedNot Applicable
New MRI Techniques for Diagnosis and Treatment of Patients With Abdominal Aortic Aneurysms
Netherlands66 participantsStarted 2023-05-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Surveillance: correlation between growth rate and MRI derived parameters
Timeframe: 1 year
2
EVAR planning: correlation between morphological parameters measured based on MRA and CTA
Timeframe: half year
3
EVAR follow up: difference in MRI parameters between patients with endoleaks and without
Timeframe: 1 year
Trial details
NCT IDNCT05976711
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)