Magnetic Resonance Direct Thrombus Imaging for Suspected Thrombosis of Upper Extremity Diagnostic Evaluation (Selene Study)
Completed
- Conditions
- arm vein thrombosisupper extremity thrombosis10014523
- Registration Number
- NL-OMON50636
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
- Patients with a clinically suspected symptomatic acute UEDVT, confirmed or
excluded by the diagnostic algorithm according to current clinical practice.
- Aged 18 years and older, willing and able to give informed consent
Exclusion Criteria
Patients are excluded if the duration of the complaints lasted more than 10
days, or if they have suspected ipsilateral recurrent UEDVT, if they have a MRI
contra-indication,or if it is impossible to perform MRDTI within 48 hours.
Patients with upper-limb amputation and those with a medical condition,
associated illness, or co-morbid circumstances that made it unlikely that the
study procedure would be completed are also excluded.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameters are the expected sensitivity and specificity of<br /><br>MRDTI for diagnosing acute arm vein thrombosis. The sensitivity of MRDTI is<br /><br>determined by calculating to proportion of scans that are read as positive for<br /><br>acute arm vein thrombosis and the specificity is determined by calculating the<br /><br>proportion of scans that are read as negative for acute arm vein thrombosis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints are 1) the optimization of the MRDTI scan sequences 2)<br /><br>the assessment of interobserver agreement between the reviewers</p><br>