Biomarker Profiling in Abdominal Aortic Aneurysm Patients (BIOMArCS-AAA)

Study of Biomarker Profiling to Unravel the Intertwined Pathophysiology of Coronary Artery Disease and Abdominal Aortic Aneurysm

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm

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 Type: Observational
• Enrollment (Anticipated): 440

Contacts and Locations

• Study Contact: Name: Isabella Kardys, MD, PhD; Phone Number: +31650032051; Email: i.kardys@erasmusmc.nl
• Study Contact Backup: Name: Eric Boersma, MSc, PhD; Phone Number: +31107031814; Email: h.boersma@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus Medical Center
      • Contact: Isabella Kardys, MD, PhD; Phone Number: +31650032051; Email: i.kardys@erasmusmc.nl
      • Contact: Hence JM Verhagen, MD, PhD; Phone Number: +31107033588; Email: h.verhagen@erasmusmc.nl
    • Rotterdam, Zuid-Holland, Netherlands, 3079DZ
      • Recruiting
      • Maasstad Ziekenhuis
      • Contact: Bram Fioole, MD, PhD; Phone Number: +31102912245; Email: fiooleb@maasstadziekenhuis.nl
      • Contact: Liesbeth C Terlouw-Punt, MANP; Phone Number: +31102912245; Email: terlouwl@maasstadziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with an abdominal aortic aneurysm, visiting the outpatient clinic.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Outcome Measure	Measure Description	Time Frame
Maximal diameter of the aneurysm	Maximal diameter of the aneurysm by CT scan imaging	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	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.	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.	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).	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	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).	Measured repeatedly during 24 months of follow-up in the longitudinal part of the study.

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Biomarkers; Abdominal Aortic Aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: MEC-2017-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No