Study of Biomarker Profiling to Unravel the Intertwined Pathophysiology of Coronary Artery Disease and Abdominal Aortic Aneurysm
Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:
• 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)
Locations
Other Locations
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Maasstad Ziekenhuis
RECRUITING
Rotterdam
Contact Information
Primary
Isabella Kardys, MD, PhD
i.kardys@erasmusmc.nl
+31650032051
Backup
Eric Boersma, MSc, PhD
h.boersma@erasmusmc.nl
+31107031814
Time Frame
Start Date:2017-03-23
Estimated Completion Date:2024-08
Participants
Target number of participants:440
Treatments
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.