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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32134

Enrollment

Registered

2008-05-07

Start date

2008-11-03

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep venous thrombosis thrombosis of the leg

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary study parameters are the sensitivity and specificity of MRDTI for diagnosing acute recurrent DVT. The sensitivity of MRDTI is determined by calculating the proportion of scans that are read as "positive for acute recurrent DVT" in group 1 patients and the specificity is determined by calculating the proportion of scans that are read as " negative for acute DVT" in group 2 patients. "	—

Secondary

Measure	Time frame
Doesn't apply	—

Countries

Netherlands

Outcome results