Abnormalities of the major venous system. MedDRA version: 9.1 Level: LLT Classification code 10047184 Term: Vein disorder
Conditions
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients over 18 years of age who have been routinely referred for an MR angiography examination to assess the major thoraco-abdominal veins (including in the neck) in respect of venous access. 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: The presence of any of the following will preclude patient inclusion: - Age of the patient under 18 years. - Contraindication to MRI (eg. Pacemaker, aneurysm clips, orbital metal) - Contraindication to intravenous gadolinium agents (eg. Contrast medium allergy). In Addenbrooke’s Hospital, this includes patients with liver transplants and patients with impaired renal function (GFR of less than 60 ml/min/1.73 m2) - Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): After completion of 30 MR angiography studies assessing the venous system.;Main Objective: To assess image quality in terms of vessel conspicuity using a five-point scale - excellent (optimal visualisation of the vessel with no signal loss), good (slight signal loss but good overall visualisation of the vessel), moderate (decreased signal intensity but images remain diagnostic), poor (insufficient signal intensity such that the vessel is not completely identifiable and the image is not diagnostic, or very poor (no or hardly any signal intensity and the vessel cannot be identified).;Secondary Objective: To assess for stenosis using a six-point scale – no (0%) stenosis, mild (1-30%) stenosis, mild-to-moderate (31-50%) stenosis, moderate (51-75%) stenosis, severe (76-99%) stenosis, or total vessel occlusion. To assess for additional thrombosis using a three-point scale – no thrombosis, partial thrombosis, complete thrombosis. To assess for the presence of artifacts as rated by a three-point scale – none, mild (artifacts present but not impairing diagnostic information), or major (extensive artifacts impair diagnosis). | — |
Countries
United Kingdom
Outcome results
None listed