New MRI techniques for diagnosing and treating abdominal aortic aneurysms
Gamechanger: Development of MRI Based Endovascular Procedures for Vascular Surgery
This study is testing new MRI techniques to see if they can better diagnose and manage abdominal aortic aneurysms without using radiation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Amsterdam, Noord-Holland) |
| Trial ID | NCT05976711 on ClinicalTrials.gov |
What this trial studies
This study explores advanced MRI techniques, including 4D flow MRI and DCE MRI, to improve the diagnosis and management of abdominal aortic aneurysms (AAA) without rupture. The goal is to replace traditional imaging methods like CT and ultrasound, which have limitations in predicting rupture risk and expose patients to radiation. By utilizing MRI, the study aims to enhance the accuracy of AAA assessments and reduce complications associated with current follow-up protocols. Participants will include patients diagnosed with AAA who meet specific criteria for surveillance, planning, or follow-up.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with AAA, particularly those with a maximum diameter between 3-5 cm who are not scheduled for immediate repair.
Not a fit: Patients with ruptured AAAs or those who have undergone previous surgical repair for their AAA will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate assessments of AAA, reducing the risk of rupture and improving patient outcomes.
How similar studies have performed: While the use of MRI in AAA management is gaining interest, this specific approach utilizing advanced MRI techniques is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam, Noord-Holland
- Amsterdam UMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.