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Predicting aneurysm growth and rupture with longitudinal biomarkers

Predicting aneurysm growth and rupture with longitudinal biomarkers - PARIS-study & Pearl AAA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49399
Enrollment
750
Registered
2019-11-29
Start date
2017-10-04
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal aortic aneurysm

Interventions

Aneurysm growth
Aneurysm rupture
Aortic Aneurysm
Biomarkers

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Adult person (18 years or older) - Person has an abdominal aortic aneurysm or has previously been treated for an abdominal aortic aneurysm - Adequate comprehension of the Dutch language to provide written informed consent

Exclusion criteria

Exclusion criteria: - A patient who is decisionally impaired. The only exception to this are patients who are decisionally impaired due to effects of an acute abdominal aortic aneurysm. This particular group is eligible for participation

Design outcomes

Primary

MeasureTime frame
Primary study parameters/outcomes •AAA growth (mm/y). This will be measured using repeated imaging with either ultrasound, CT or MRI. •AAA rupture. This is defined as acute haemorrhage from the aneurysm outside the true aortic wall with the presence of intra-peritoneal and/or retroperitoneal blood at imaging, or observed during repair. •Death •Serum levels of cytokines (including, but not limited to IL- 6) •Serum levels of proteases (including, but not limited to MMP-9) •Protease and cytokine levels in aortic tissue

Secondary

MeasureTime frame
Secondary study parameters/outcomes •During the course of the study, additional study parameters will be collected, as part of regular clinical care. For a full overview of all study parameters collected, please see the clinical data items titled PRISMA. PRISMA will contain all parameters collected during this project. Due to the longitudinal nature of this project, PRISMA may be subject to change. •Incidence of complications after AAA repair •Type of complications after AAA repair

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)