MAGNetic Resonance Direct Thrombus Imaging for Suspected Thrombosis of Upper Extremity Diagnostic Evaluation (MAGNITUDE Study)
- Conditions
- pper Extremity Deep Vein Thrombosis
- Registration Number
- NL-OMON20594
- Lead Sponsor
- eiden University Medical Center (LUMC), Leiden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 63
Inclusion Criteria
1)A clinically suspected symptomatic acute UEDVT;
2)Onset of symptoms <10 days;
Exclusion Criteria
1)Suspected ipsilateral recurrent UEDVT (previous UEDVT objectively diagnosed in the same arm);
2)MRI contra-indication (including but not limited to a cardiac pacemaker or subcutaneous defibrillator; vascular clips in the cerebral vessels; metal splinter in the eye, a hearing aid that cannot be removed; a neurostimulator that cannot be removed; a hydrocephalus pump);
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The sensitivity and specificity of MRDTI for the diagnosis of UEDVT
- Secondary Outcome Measures
Name Time Method The secondary endpoints are 1) the optimization of the MRDTI scan sequences 2) the assessment of interobserver agreement between the reviewers; 3) the evaluation of the sensitivity, specificity, negative predictive value and positive predictive value of the clinical prediction rule and D-dimer test; 4) subgroup analysis for inpatient and outpatient groups, patients with and without malignancy and UEDVT that is and is not secondary to a central venous catheter.