Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03703947

Biomarker Profiling in Abdominal Aortic Aneurysm Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus Medical Center, Rotterdam, South Holland, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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

Treatment and study plan

Primary outcomes

  1. Volume of the aneurysm sac

    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.

    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 outcomes

  1. Maximal diameter of the aneurysm

    Time frame: 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

  2. Number of deceased patients due to all-cause mortality

    Time frame: During 24 months of follow-up in the longitudinal part of the study.

    All-cause mortality

  3. Number of AAA-related adverse events in watchful waiting group

    Time frame: 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.

  4. Number of AAA-related adverse events in EVAR patients

    Time frame: 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.

  5. Number of patients with cardiovascular events

    Time frame: 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).

  6. Quality of life measured according to the EuroQol questionnaire

    Time frame: 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

  7. Depression measured according to the Hospital Anxiety and Depression Scale questionnaire

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Boersma, MSc, PhD

CONTACT

[email protected]

+31107031814

Isabella Kardys, MD, PhD

CONTACT

[email protected]

+31650032051

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Maasstad Hospital

Registry information

Official study title

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

Acronym: BIOMArCS-AAA

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2018
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.