Abdominal aortic aneurysms. Biomarkers related to diminished aneurysm wall strength. MedDRA version: 9.1 Level: LLT Classification code 10000051 Term: Abdominal aneurysm
Conditions
Sponsors
UMC St Radboud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Forty patients scheduled for conventional repair of an asymptomatic or symptomatic (non-ruptured) aneurysm. · Informed consent · Clinical condition allows MR imaging (USPIO group) · Preoperative CT (computer tomography) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Ruptured aneurysm · Patient characteristics and aneurysm anatomy suitable for endovascular repair · Contraindication for MR imaging like metallic implants or claustrophobia (USPIO group). · Previous aortic aneurysm surgery · Severe cardiac co-morbidity (e.g. Chronic Heart Failure, Caronary artery disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Since rupture of an Abdominal Aortic Aneurysm (AAA) is potentially lethal, preventive surgical repair is warranted when the risk of rupture exceeds the risk of complications following surgery. Aneurysm rupture occurs when the forces acting on the aneurysm wall (stress) surpass aneurysm wall strength. Information on both wall stress and strength might therefore improve patient selection for prophylactic repair and reduce aneurysm related mortality. Although aneurysm wall stress calculations are possible, no in vivo method exists to determine aneurysm wall strength. This study is designed to identify possible in vivo biochemical (integrity of the extracellular matrix) and biological (inflammation; macrophage infiltration)markers related to aneurysm wall strength. ;Secondary Objective: 1. To establish the relationship between Extracellular Matrix (ECM) degradation (loss of specific glucosaminoglycans and glycoproteins) and aneurysm wall tensile strength. 2. To correlate USPIO (Sinerem) uptake in infiltrated macrophages with aneurysm wall tensile strength. ;Primary end point(s): Main study parameters/endpoints · Aneurysm wall tensile strength (maximal load before failure); N/mm · USPIO enhanced MRI, drop in relative signal intensity (SI); rSI = SIAAA/SIpsoas. · Histology, USPIO uptake in macrophages; number of macrophages containing iron on a 5-point scale; 0 no, 1 hardly any, 2 some, 3 many and 4 very many. · MMP tissue content; arbitrary units per mg proteins in the tissue extract · Glucosaminoglycans (Gag); mg of Gag-derived uronic acid/g of dry defatted tissue. · Glycoproteins; enzyme-liked immunosorbent Assay (ELISA), µg/ml · Collagen/elastin content; electon microscopy, number of intact fibres per unit area. | — |
Countries
Netherlands
Outcome results
None listed