Biomarker Profiling in Abdominal Aortic Aneurysm Patients

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

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

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.

Study Type

Observational

Primary Outcome

Volume of the aneurysm sac

Secondary Outcome

 Maximal diameter of the aneurysm

Condition

Abdominal Aortic Aneurysm

Study Arms / Comparison Groups

 Watchful-waiting group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

440

Start Date

March 23, 2017

Completion Date

August 2024

Primary Completion Date

August 2024

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

Gender

All

Ages

18 Years - N/A

Contacts

Isabella Kardys, MD, PhD, +31650032051, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT03703947

Organization ID

MEC-2017-019

Responsible Party

Principal Investigator

Study Sponsor

Erasmus Medical Center

Collaborators

 Maasstad Hospital

Study Sponsor

Isabella Kardys, MD, PhD, Study Chair, Erasmus Medical Center

Verification Date

March 2022