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

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ClinicalTrials.gov Identifier: NCT03703947
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : February 8, 2021
Sponsor:
Collaborator:
Maasstad Hospital
Information provided by (Responsible Party):
Isabella Kardys, Erasmus Medical Center

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 440 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Biomarker Profiling to Unravel the Intertwined Pathophysiology of Coronary Artery Disease and Abdominal Aortic Aneurysm
Actual Study Start Date : March 23, 2017
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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).


Biospecimen Retention:   Samples With DNA
Blood (EDTA plasma, citrate plasma, serum, DNA) is taken at the day of inclusion and at follow-up visits, which will be performed every 6 months, until the end of the 2-years scheduled follow-up.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with an abdominal aortic aneurysm, visiting the outpatient clinic.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703947


Contacts
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Contact: Isabella Kardys, MD, PhD +31650032051 i.kardys@erasmusmc.nl
Contact: Eric Boersma, MSc, PhD +31107031814 h.boersma@erasmusmc.nl

Locations
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Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015GD
Contact: Hence JM Verhagen, MD, PhD    +31107033588    h.verhagen@erasmusmc.nl   
Contact: Isabella Kardys, MD, PhD    +31650032051    i.kardys@erasmusmc.nl   
Maasstad Ziekenhuis Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3079DZ
Contact: Bram Fioole, MD, PhD    +31102912245    fiooleb@maasstadziekenhuis.nl   
Contact: Liesbeth C Terlouw-Punt, MANP    +31102912245    terlouwl@maasstadziekenhuis.nl   
Sponsors and Collaborators
Erasmus Medical Center
Maasstad Hospital
Investigators
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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
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Responsible Party: Isabella Kardys, Principal investigator, associate professor, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03703947    
Other Study ID Numbers: MEC-2017-019
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isabella Kardys, Erasmus Medical Center:
Abdominal Aortic Aneurysm
Biomarkers
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases