BIOMArCS-AAA: Biomarker Profiling in Abdominal Aortic Aneurysm Patients
Study Details
Study Description
Brief 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 biomarkers for the main genetic pathways associated with AAA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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| 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. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- Volume of the aneurysm sac [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.
Secondary Outcome Measures
- Maximal diameter of the aneurysm [Measured cross-sectionally, as well as repeatedly in the longitudinal part of the study during 24 months of follow-up.]
Maximal diameter of the aneurysm by CT scan imaging
- Number of deceased patients due to all-cause mortality [During 24 months of follow-up in the longitudinal part of the study.]
All-cause mortality
- Number of AAA-related adverse events in watchful waiting group [During 24 months of follow-up in the watchful-waiting patients of the longitudinal part of the study.]
AAA related death, AAA rupture, or any AAA-related intervention.
- Number of AAA-related adverse events in EVAR patients [During 24 months of follow-up in the EVAR patients of the longitudinal part of the study.]
Endoleaks, migration >10 mm, device integrity failure, AAA-related death, late postimplantation AAA rupture, or any AAA-related secondary intervention.
- Number of patients with cardiovascular events [Cross-sectionally and during 24 months of follow-up in the longitudinal part of the study.]
Cardiovascular events: i.e. cardiovascular death, myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG).
- Quality of life measured according to the EuroQol questionnaire [Measured repeatedly during 24 months of follow-up in the longitudinal part of the study.]
The validated questionnaire EuroQol will be used to assess health related quality of life
- Depression measured according to the Hospital Anxiety and Depression Scale questionnaire [Measured repeatedly during 24 months of follow-up in the longitudinal part of the study.]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age of 18 years or older
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Capable of understanding and signing informed consent AND one of the following
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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)
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Planned to undergo EVAR for AAA (Prospective longitudinal study, Arm 2 EVAR group)
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Underwent EVAR for AAA in past years (Cross-sectional study)
Exclusion Criteria:
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Patients with isolated iliac artery aneurysm, traumatic aneurysm, anastomotic aneurysm and infectious aneurysm
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Patients with a clinical diagnosed thoracic aneurysm (i.e. located in the chest, above the diaphragm)
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Coexistent condition with life expectancy ≤ 1 year
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Dialysis dependent, (end stage) renal disease patients
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Women of childbearing age
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Linguistic barrier
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Unlikely to appear at all scheduled follow-up visits
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus Medical Center | Rotterdam | Zuid-Holland | Netherlands | 3015GD |
| 2 | Maasstad Ziekenhuis | Rotterdam | Zuid-Holland | Netherlands | 3079DZ |
Sponsors and Collaborators
- Erasmus Medical Center
- Maasstad Hospital
Investigators
- Study Chair: Isabella Kardys, MD, PhD, Erasmus Medical Center
- Study Director: Eric Boersma, MSc, PhD, Erasmus Medical Center
- Principal Investigator: Hence JM Verhagen, MD, PhD, Erasmus Medical Center
- Principal Investigator: Bram Fioole, MD, PhD, Maasstad Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MEC-2017-019