Clinical trial NCT03703947: Biomarker Profiling in Abdominal Aortic Aneurysm Patients
Official title: Study of Biomarker Profiling to Unravel the Intertwined Pathophysiology of Coronary Artery Disease and Abdominal Aortic Aneurysm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal Aortic Aneurysm
Biomarkers
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Maasstad Hospital
First posted: 2018-10-12
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an abdominal aortic aneurysm, visiting the outpatient clinic.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* 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 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

Primary outcomes:
measure: Volume of the aneurysm sac
timeFrame: 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:
measure: Maximal diameter of the aneurysm
timeFrame: Measured cross-sectionally, as well as repeatedly in the longitudinal part of the study during 24 months of follow-up.
measure: Number of deceased patients due to all-cause mortality
timeFrame: During 24 months of follow-up in the longitudinal part of the study.
measure: Number of AAA-related adverse events in watchful waiting group
timeFrame: During 24 months of follow-up in the watchful-waiting patients of the longitudinal part of the study.
measure: Number of AAA-related adverse events in EVAR patients
timeFrame: During 24 months of follow-up in the EVAR patients of the longitudinal part of the study.
measure: Number of patients with cardiovascular events
timeFrame: Cross-sectionally and during 24 months of follow-up in the longitudinal part of the study.
measure: Quality of life measured according to the EuroQol questionnaire
timeFrame: Measured repeatedly during 24 months of follow-up in the longitudinal part of the study.
measure: Depression measured according to the Hospital Anxiety and Depression Scale questionnaire
timeFrame: Measured repeatedly during 24 months of follow-up in the longitudinal part of the study.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Isabella Kardys, MD, PhD
role: STUDY_CHAIR
affiliation: Erasmus Medical Center
name: Eric Boersma, MSc, PhD
role: STUDY_DIRECTOR
affiliation: Erasmus Medical Center
name: Hence JM Verhagen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maasstad Hospital
name: Bram Fioole, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: