Performance of direct thrombus imaging by MRI in the diagnosis of acute recurrent deep-vein thrombosis

Completed

Conditions: Deep venous thrombosis
thrombosis of the leg
10014523

Registration Number: NL-OMON32134

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Group 1:
- At least 18 years of age and willing to provide informed consent
- Newly diagnosed second ipsilateral acute DVT with symptom onset within 10 days
- Non-compressibility of the common femoral vein and/or popliteal vein on compression ultrasonography in a segment that is clearly different from the first episode
- Positive D-dimer test;Group 2:
- At least 18 years of age and willing to provide informed consent
- Chronic symptoms of postthrombotic syndrome, but no symptoms of acute DVT
- Complete or partial non-compressibility of 1 or more proximal deep veins on compression ultrasonography
-The last deep vein thrombosis has been longer than 6 months ago
- Negative D-dimer test

Exclusion Criteria

- Younger than 18 years of age
- Patients who received an investigational drug within 30 days of enrolment
- Patients who have undergone a study with MRI in the previous 48 hours
- Patients with lower limb amputation
- Patients with a medical condition, associated illness, or co-morbid circumstances that made it unlikely that the study procedure would be completed
- Patients with a MRI contra-indication:
- A pacemaker or subcutaneous defibrillator of the heart
- Clips in the vascular system of the brains
- Metal fragments in the eye
- An hearing aid which cann't be removed
- A neurostimulator which cann't be removed
- An hydrocephalus pump
- Denture which are fixed by magnets
- A metal intrauterine device
- (The possibility of) being pregnant
- Claustrophobic

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters are the sensitivity and specificity of MRDTI for<br /><br>diagnosing acute recurrent DVT. The sensitivity of MRDTI is determined by<br /><br>calculating the proportion of scans that are read as positive for acute<br /><br>recurrent DVT in group 1 patients and the specificity is determined by<br /><br>calculating the proportion of scans that are read as negative for acute DVT<br /><br>in group 2 patients. </p><br>

Secondary Outcome Measures