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| Name | Class |
|---|---|
| Maasstad Hospital | OTHER |
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The BIOMArCS-AAA study aims to investigate the associations of (temporal patterns of) blood biomarkers with aneurysm growth in patients with abdominal aortic aneurysm (AAA), with particular attention to biomarkers that have demonstrated prognostic value for adverse disease outcomes in coronary artery disease and biomarkers for the main genetic pathways associated with AAA.
BIOMArCS-AAA is an observational, multicenter study. Patients with an abdominal aortic aneurysm (AAA) will be recruited through the vascular surgery outpatient clinic of Erasmus MC and Maasstad Ziekenhuis, the Netherlands. The prospective, longitudinal part of the study will include an arm with 120 AAA watchful waiting patients and an arm with 120 AAA patients undergoing endovascular aneurysm repair (EVAR), both with a 24-month follow-up period. Clinical data collection, and blood sampling will be conducted at baseline, at 1 month after EVAR and at 6, 12, 18 and 24 months for all patients. CT will be conducted at baseline and 12 and 24 months, plus at 1 month in the EVAR patients. Quality of life and depression questionnaires will be performed at baseline, at 12 and 24 months of follow-up in all patients, and at 1 month only in EVAR patients. Additionally, a cross-sectional study will be performed in 200 patients treated for AAA with EVAR in the past years. In these patients, clinical data collection, blood sampling, ultrasound and CT will be performed at their next regular outpatient clinic visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Watchful-waiting group | The prospective, longitudinal part of the study will include an arm with 120 AAA watchful waiting patients, with a 24-month follow-up period. Clinical data collection, and blood sampling will be conducted at baseline, and at 6, 12, 18 and 24 months for all patients. CT will be conducted at baseline and 12 and 24 months. Quality of life and depression questionnaires will be performed at baseline, at 12 and 24 months of follow-up in all patients. | ||
| EVAR group | The prospective, longitudinal part of the study will include an arm with 120 AAA patients undergoing endovascular aneurysm repair (EVAR), with a 24-month follow-up period. Clinical data collection, and blood sampling will be conducted at baseline, at 1 month after EVAR and at 6, 12, 18 and 24 months after EVAR. CT will be conducted at baseline, at 1 month after EVAR and at 12 and 24 months after EVAR patients. Quality of life and depression questionnaires will be performed at baseline, at 1 month, at 12 and 24 months of follow-up after EVAR. | ||
| Cross-sectional group (after EVAR) | A cross-sectional study will be performed in 200 patients treated for AAA with EVAR in the past years. In these patients, clinical data collection, blood sampling, ultrasound and CT will be performed at their next regular outpatient clinic visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Volume of the aneurysm sac | The primary study endpoint is volume of the aneurysm sac. This will be measured cross-sectionally, as well as repeatedly in the longitudinal part of the study by CT scan imaging during 24 months of follow-up. | Measured cross-sectionally, as well as repeatedly in the longitudinal part of the study by CT scan imaging during 24 months of follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal diameter of the aneurysm | Maximal diameter of the aneurysm by CT scan imaging | Measured cross-sectionally, as well as repeatedly in the longitudinal part of the study during 24 months of follow-up. |
| Number of deceased patients due to all-cause mortality |
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Inclusion Criteria:
Age of 18 years or older
Capable of understanding and signing informed consent AND one of the following
Exclusion Criteria:
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Patients with an abdominal aortic aneurysm, visiting the outpatient clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabella Kardys, MD, PhD | Contact | +31650032051 | i.kardys@erasmusmc.nl | |
| Eric Boersma, MSc, PhD | Contact | +31107031814 | h.boersma@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Isabella Kardys, MD, PhD | Erasmus Medical Center | Study Chair |
| Eric Boersma, MSc, PhD | Erasmus Medical Center | Study Director |
| Hence JM Verhagen, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40945875 | Derived | Vanmaele A, Karamanidou M, Branidis P, Bouwens E, Hoeks SE, de Bruin JL, Ten Raa S, Akkerhuis KM, van Lier F, Budde RPJ, Fioole B, Verhagen HJM, Boersma E, Kardys I. Abdominal aortic aneurysm growth profiles over time: Prognostic implications and biological insights. J Vasc Surg. 2026 Jan;83(1):57-66.e1. doi: 10.1016/j.jvs.2025.09.007. Epub 2025 Sep 12. | |
| 40187384 |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Blood (EDTA plasma, citrate plasma, serum, DNA) is taken at the day of inclusion and at follow-up visits, which will be performed every 6 months, until the end of the 2-years scheduled follow-up.
All-cause mortality |
| During 24 months of follow-up in the longitudinal part of the study. |
| Number of AAA-related adverse events in watchful waiting group | AAA related death, AAA rupture, or any AAA-related intervention. | During 24 months of follow-up in the watchful-waiting patients of the longitudinal part of the study. |
| Number of AAA-related adverse events in EVAR patients | Endoleaks, migration >10 mm, device integrity failure, AAA-related death, late postimplantation AAA rupture, or any AAA-related secondary intervention. | During 24 months of follow-up in the EVAR patients of the longitudinal part of the study. |
| Number of patients with cardiovascular events | Cardiovascular events: i.e. cardiovascular death, myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG). | Cross-sectionally and during 24 months of follow-up in the longitudinal part of the study. |
| Quality of life measured according to the EuroQol questionnaire | The validated questionnaire EuroQol will be used to assess health related quality of life | Measured repeatedly during 24 months of follow-up in the longitudinal part of the study. |
| Depression measured according to the Hospital Anxiety and Depression Scale questionnaire | The Hospital Anxiety and Depression Scale (HADS) will be assessed to adjust for depression and anxiety in combination with the 2-item Patient Health Questionnaire (PHQ-2). | Measured repeatedly during 24 months of follow-up in the longitudinal part of the study. |
| Erasmus Medical Center |
| Principal Investigator |
| Bram Fioole, MD, PhD | Maasstad Hospital | Principal Investigator |
| Maasstad Ziekenhuis | Recruiting | Rotterdam | South Holland | 3079DZ | Netherlands |
|
| Vanmaele A, Bouwens E, Hoeks SE, de Bruin JL, Ten Raa S, Akkerhuis KM, van Lier F, Budde RPJ, Fioole B, Verhagen HJM, Boersma E, Kardys I. The value of volume over maximum diameter for following abdominal aortic aneurysm growth and reducing surveillance visits in patients with a subthreshold aneurysm. J Vasc Surg. 2025 Jul;82(1):102-110.e3. doi: 10.1016/j.jvs.2025.03.395. Epub 2025 Apr 3. |
| 39378678 | Derived | Vanmaele A, Bouwens E, Hoeks SE, Kindt A, Lamont L, Fioole B, Budde RP, Ten Raa S, Hussain B, Oliveira-Pinto J, Ijpma AS, van Lier F, Akkerhuis KM, Majoor-Krakauer DF, de Bruin JL, Hankemeier T, de Rijke Y, Verhagen HJ, Boersma E, Kardys I. Targeted plasma multi-omics propose glutathione, glycine and serine as biomarkers for abdominal aortic aneurysm growth on serial CT scanning. Atherosclerosis. 2024 Nov;398:118620. doi: 10.1016/j.atherosclerosis.2024.118620. Epub 2024 Oct 2. |
| 37395286 | Derived | Bouwens E, Vanmaele A, Hoeks SE, Verhagen HJ, Fioole B, Moelker A, Ten Raa S, Hussain B, Oliveira-Pinto J, Bastos Goncalves F, Ijpma AS, Hoefer IE, van Lier F, Akkerhuis KM, Majoor-Krakauer DF, Boersma E, Kardys I. Circulating biomarkers of cardiovascular disease are related to aneurysm volume in abdominal aortic aneurysm. Vasc Med. 2023 Oct;28(5):433-442. doi: 10.1177/1358863X231181159. Epub 2023 Jul 3. |
| D001018 |
| Aortic Diseases |