An observational study in Abdominal Aortic Aneurysm, sponsored by Erasmus Medical Center. Status unknown at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Erasmus Medical Center · Observational
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.
481 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 440 is above the median of 167 across 225 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
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Patients with an abdominal aortic aneurysm, visiting the outpatient clinic.
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Exclusion Criteria:
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.
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.
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.
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.
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.
Maximal diameter of the aneurysm
Maximal diameter of the aneurysm by CT scan imaging
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
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
AAA related death, AAA rupture, or any AAA-related intervention.
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
Endoleaks, migration \>10 mm, device integrity failure, AAA-related death, late postimplantation AAA rupture, or any AAA-related secondary intervention.
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
Cardiovascular events: i.e. cardiovascular death, myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG).
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
The validated questionnaire EuroQol will be used to assess health related quality of life
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
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).
Time frame: Measured repeatedly during 24 months of follow-up in the longitudinal part of the study.
Plan to share: Undecided
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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