Biomarker Profiling in Abdominal Aortic Aneurysm Patients

NCT03703947 | Recruiting

• 1 other identifier: MEC-2017-019
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 2

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Maximal diameter of the aneurysm

  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

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

• Number of AAA-related adverse events in watchful waiting group

  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

  During 24 months of follow-up in the EVAR patients of the longitudinal part of the study.

• Number of patients with cardiovascular events

  Cross-sectionally and during 24 months of follow-up in the longitudinal part of the study.

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Maasstad Hospital: collaborator

Study Sites (2)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Maasstad Ziekenhuis

Rotterdam, South Holland, 3079DZ, Netherlands

RECRUITING

Related Publications (2)

• Vanmaele A, Bouwens E, Hoeks SE, Kindt A, Lamont L, Fioole B, Budde RP, Ten Raa S, Hussain B, Oliveira-Pinto J, Ijpma AS, van Lier F, Akkerhuis KM, Majoor-Krakauer DF, de Bruin JL, Hankemeier T, de Rijke Y, Verhagen HJ, Boersma E, Kardys I. Targeted plasma multi-omics propose glutathione, glycine and serine as biomarkers for abdominal aortic aneurysm growth on serial CT scanning. Atherosclerosis. 2024 Nov;398:118620. doi: 10.1016/j.atherosclerosis.2024.118620. Epub 2024 Oct 2.

  PMID: 39378678 DERIVED

• Bouwens E, Vanmaele A, Hoeks SE, Verhagen HJ, Fioole B, Moelker A, Ten Raa S, Hussain B, Oliveira-Pinto J, Bastos Goncalves F, Ijpma AS, Hoefer IE, van Lier F, Akkerhuis KM, Majoor-Krakauer DF, Boersma E, Kardys I. Circulating biomarkers of cardiovascular disease are related to aneurysm volume in abdominal aortic aneurysm. Vasc Med. 2023 Oct;28(5):433-442. doi: 10.1177/1358863X231181159. Epub 2023 Jul 3.

  PMID: 37395286 DERIVED

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.

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Isabella Kardys, MD, PhD

  Erasmus Medical Center

  STUDY CHAIR

• Eric Boersma, MSc, PhD

  Erasmus Medical Center

  STUDY DIRECTOR

• Hence JM Verhagen, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Bram Fioole, MD, PhD

  Maasstad Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabella Kardys, MD, PhD

CONTACT

+31650032051; i.kardys@erasmusmc.nl

Eric Boersma, MSc, PhD

CONTACT

+31107031814; h.boersma@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, associate professor

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 12, 2018
• Study Start: March 23, 2017
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

NL (2)