Biomarker Profiling in Abdominal Aortic Aneurysm Patients
NCT ID: NCT03703947
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
440 participants
OBSERVATIONAL
2017-03-23
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Maasstad Hospital
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Isabella Kardys
Principal investigator, associate professor
Principal Investigators
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Isabella Kardys, MD, PhD
Role: STUDY_CHAIR
Erasmus Medical Center
Eric Boersma, MSc, PhD
Role: STUDY_DIRECTOR
Erasmus Medical Center
Hence JM Verhagen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Bram Fioole, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maasstad Hospital
Locations
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Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Maasstad Ziekenhuis
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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MEC-2017-019
Identifier Type: -
Identifier Source: org_study_id
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