Abdominal Aortic AneurysmBIOMArCS-AAANCT03703947
Biomarker Profiling in Abdominal Aortic Aneurysm Patients
An observational study of Abdominal Aortic Aneurysm, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 440 participants
- Where
- 2 sitesNetherlands
- Study dates
- 23 Mar 2017to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with an abdominal aortic aneurysm, visiting the outpatient clinic.
Who may be able to join
- Age of 18 years or older
- Capable of understanding and signing informed consent AND one of the following
- 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)
- Planned to undergo EVAR for AAA (Prospective longitudinal study, Arm 2 EVAR group)
- Underwent EVAR for AAA in past years (Cross-sectional study)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Hence JM Verhagen, MD, PhD, +31107033588, h.verhagen@erasmusmc.nl
Isabella Kardys, MD, PhD, +31650032051, i.kardys@erasmusmc.nl
- Recruiting
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079DZ
Bram Fioole, MD, PhD, +31102912245, fiooleb@maasstadziekenhuis.nl
Liesbeth C Terlouw-Punt, MANP, +31102912245, terlouwl@maasstadziekenhuis.nl
About this study
Official title: Study of Biomarker Profiling to Unravel the Intertwined Pathophysiology of Coronary Artery Disease and Abdominal Aortic Aneurysm
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.
Read the detailed description
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.
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm, Biomarkers
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured cross-sectionally, as well as repeatedly in the longitudinal part of the study by CT scan imaging during 24 months of follow-up.
Secondary outcomes (7)
Maximal diameter of the aneurysm
Maximal diameter of the aneurysm by CT scan imaging
Measured: 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
All-cause mortality
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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: 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: Measured repeatedly during 24 months of follow-up in the longitudinal part of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start23 Mar 2017
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maasstad Hospital
- Responsible party
- Principal investigator, Isabella Kardys, Erasmus Medical Center
- Investigators
- Isabella Kardys, MD, PhD, Study chair, Erasmus Medical CenterEric Boersma, MSc, PhD, Study director, Erasmus Medical CenterHence JM Verhagen, MD, PhD, Principal investigator, Erasmus Medical CenterBram Fioole, MD, PhD, Principal investigator, Maasstad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703947
- Sponsor's protocol ID
- MEC-2017-019
- Acronym
- BIOMArCS-AAA
- Status last verified
- Jul 2024
- First submitted
- 8 Oct 2018
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40945875Vanmaele 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.
PubMed 40187384Vanmaele 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.
PubMed 39378678Bouwens 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.
PubMed 37395286
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Biomarker Profiling to Unravel the Intertwined Pathophysiology of Coronary Artery Disease and Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT03703947
- Acronym / sponsor ID
- BIOMArCS-AAA / MEC-2017-019
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Maasstad Hospital
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with an abdominal aortic aneurysm, visiting the outpatient clinic.
Key inclusion criteria (5 listed)
- Age of 18 years or older
- Capable of understanding and signing informed consent AND one of the following
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volume of the aneurysm sac
Time frame: Measured cross-sectionally, as well as repeatedly in the longitudinal part of the study by CT scan imaging during 24 months of follow-up.
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.
7 secondary outcomes
Maximal diameter of the aneurysm
Time frame: 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
Time frame: During 24 months of follow-up in the longitudinal part of the study.
Number of AAA-related adverse events in watchful waiting group
Time frame: 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
Time frame: During 24 months of follow-up in the EVAR patients of the longitudinal part of the study.
Number of patients with cardiovascular events
Time frame: 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
Time frame: 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
Time frame: Measured repeatedly during 24 months of follow-up in the longitudinal part of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Derived from this study: PubMed 40945875Vanmaele 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.
- Derived from this study: PubMed 40187384Vanmaele 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.
- Derived from this study: PubMed 39378678Vanmaele 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.
- Derived from this study: PubMed 37395286Bouwens 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabella Kardys, MD, PhD study chair
Erasmus Medical Center
Eric Boersma, MSc, PhD study director
Erasmus Medical Center
Hence JM Verhagen, MD, PhD principal investigator
Erasmus Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Erasmus Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabella Kardys, MD, PhD (+31650032051, i.kardys@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of the aneurysm sac (time frame: Measured cross-sectionally, as well as repeatedly in the longitudinal part of the study by CT scan imaging during 24 months of follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03703947, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.