Abdominal aortic aneurysm growth profiles over time: Prognostic implications and biological insights.
Alexander Vanmaele, Maria Karamanidou, Petros Branidis...
https://pubmed.ncbi.nlm.nih.gov/40945875Actively Recruiting
Age: 18Years +
All Genders
ID03703947
Study of Biomarker Profiling to Unravel the Intertwined Pathophysiology of Coronary Artery Disease and Abdominal Aortic Aneurysm
Led by Erasmus Medical Center · Updated on 2024-07-16
440
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
M
Maasstad Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying abdominal aortic aneurysm (AAA) to understand how blood biomarkers relate to aneurysm growth. This observational, multicenter study focuses on biomarkers linked to coronary artery disease and genetic pathways associated with AAA. The aim is to better understand the disease process by tracking these markers over time in patients with AAA. The study includes three groups: 120 patients with AAA under watchful waiting, 120 patients undergoing endovascular aneurysm repair (EVAR), and 200 patients previously treated with EVAR. For the watchful waiting and EVAR groups, clinical data and blood samples are collected at baseline and multiple follow-up points over 24 months. CT scans and questionnaires on quality of life and depression are also performed at specified intervals. The cross-sectional group undergoes clinical assessments, blood tests, ultrasound, and CT during their regular clinic visit. Participants will be closely monitored through regular visits involving blood sampling, imaging, and questionnaires to assess aneurysm volume, diameter, and patient well-being. The study tracks adverse events, mortality, and cardiovascular incidents over two years. The primary measurement is aneurysm sac volume monitored by CT scans. The study aims to gather detailed data to clarify disease progression and patient outcomes during the follow-up period.
CONDITIONS
Brief Title
Biomarker Profiling in Abdominal Aortic Aneurysm Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age of 18 years or older
- Able to understand and sign informed consent
- Have a diagnosis of abdominal aortic aneurysm (AAA) with diameter ≥40mm and managed by watchful waiting
- Are planning to undergo endovascular aneurysm repair (EVAR) for AAA
- Have undergone EVAR for AAA in past years (for cross-sectional study)
You will not qualify if you...
- Have isolated iliac artery aneurysm, traumatic aneurysm, anastomotic aneurysm, or infectious aneurysm
- Have a clinically diagnosed thoracic aneurysm (above the diaphragm)
- Have a coexisting condition with life expectancy of 1 year or less
- Are dependent on dialysis or have end-stage renal disease
- Are women of childbearing age
- Have a language barrier preventing participation
- Are unlikely to attend all scheduled follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 24 months
Participants who are under watchful waiting for abdominal aortic aneurysm are observed with clinical data collection, blood sampling, CT scans, and questionnaires over time.
Visits at baseline, and at 6, 12, 18, and 24 months
Monitoring
Duration - 24 months
Participants undergoing endovascular aneurysm repair (EVAR) are observed with clinical data collection, blood sampling, CT scans, and questionnaires before and after the procedure over 24 months.
Visits at baseline, 1 month, and at 6, 12, 18, and 24 months post-EVAR
Surveillance
Duration - 1 visit
Participants who have previously undergone EVAR are observed during a regular outpatient clinic visit with clinical data collection, blood sampling, ultrasound, and CT scans.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GD
Actively Recruiting
2
Maasstad Ziekenhuis
Rotterdam, South Holland, Netherlands, 3079DZ
Actively Recruiting
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Research Team
I
Isabella Kardys, MD, PhD
E
Eric Boersma, MSc, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
The value of volume over maximum diameter for following abdominal aortic aneurysm growth and reducing surveillance visits in patients with a subthreshold aneurysm.
Alexander Vanmaele, Elke Bouwens, Sanne E Hoeks...
https://pubmed.ncbi.nlm.nih.gov/40187384Targeted plasma multi-omics propose glutathione, glycine and serine as biomarkers for abdominal aortic aneurysm growth on serial CT scanning.
Alexander Vanmaele, Elke Bouwens, Sanne E Hoeks...
https://pubmed.ncbi.nlm.nih.gov/39378678Circulating biomarkers of cardiovascular disease are related to aneurysm volume in abdominal aortic aneurysm.
Elke Bouwens, Alexander Vanmaele, Sanne E Hoeks...
https://pubmed.ncbi.nlm.nih.gov/37395286