Investigating blood biomarkers in patients with abdominal aortic aneurysm
Study of Biomarker Profiling to Unravel the Intertwined Pathophysiology of Coronary Artery Disease and Abdominal Aortic Aneurysm
This study is trying to see if certain blood markers can help predict how abdominal aortic aneurysms grow and affect patients over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 2 sites (Rotterdam, South Holland and 1 other locations) |
| Trial ID | NCT03703947 on ClinicalTrials.gov |
What this trial studies
The BIOMArCS-AAA study examines the relationship between blood biomarkers and the growth of abdominal aortic aneurysms (AAA). This observational, multicenter study will recruit patients from the vascular surgery outpatient clinics of Erasmus MC and Maasstad Ziekenhuis in the Netherlands. It includes a longitudinal follow-up of patients undergoing watchful waiting and those undergoing endovascular aneurysm repair (EVAR), with data collection at multiple time points over 24 months. The study aims to identify biomarkers that may predict adverse outcomes in AAA patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with AAA of 40mm or more, either managed through watchful waiting or scheduled for EVAR.
Not a fit: Patients with isolated iliac artery aneurysms, thoracic aneurysms, or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for patients with abdominal aortic aneurysms.
How similar studies have performed: Other studies have shown promise in using biomarkers for monitoring AAA, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of 18 years or older * Capable of understanding and signing informed consent AND one of the following 1. Diagnosis of AAA, with a diameter ≥40mm, based on any imaging technique and treated by watchful waiting strategy (Prospective longitudinal study, Arm 1 watchful waiting group) 2. Planned to undergo EVAR for AAA (Prospective longitudinal study, Arm 2 EVAR group) 3. Underwent EVAR for AAA in past years (Cross-sectional study) Exclusion Criteria: * Patients with isolated iliac artery aneurysm, traumatic aneurysm, anastomotic aneurysm and infectious aneurysm * Patients with a clinical diagnosed thoracic aneurysm (i.e. located in the chest, above the diaphragm) * Coexistent condition with life expectancy ≤ 1 year * Dialysis dependent, (end stage) renal disease patients * Women of childbearing age * Linguistic barrier * Unlikely to appear at all scheduled follow-up visits
Where this trial is running
Rotterdam, South Holland and 1 other locations
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
- Maasstad Ziekenhuis — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Hence JM Verhagen, MD, PhD — Erasmus Medical Center
- Study coordinator: Isabella Kardys, MD, PhD
- Email: i.kardys@erasmusmc.nl
- Phone: +31650032051
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.