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Optimizing diagnosis of abdominal vein thrombosis with MRI- the Rhea study

Optimizing diagnosis of splanchnic vein thrombosis with MR Direct Thrombus Imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21809
Enrollment
73
Registered
2018-02-28
Start date
2018-08-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

None listed

Interventions

This study is a prospective diagnostic proof of concept study to explore the diagnostic accuracy of MRDTI in the diagnostic management of acute and chronic SVT. This will be achieved by performing MRD

Sponsors

LUMC (Leids Universitair Medisch Centrum)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Patients with confirmed acute SVT; definitions provided in paragraph 4.2 (Cases, group 1) - Patients with confirmed non-symptomatic chronic SVT, defined by incident SVT treated for at least 3 months and with chronic thrombi on 2 serial imaging tests with at least 3 months interval (controls, group 2) - Aged 18 years and older - Willing and able to give informed consent

Exclusion criteria

Exclusion criteria: - 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) - A medical condition, associated illness or co-morbid circumstances that precludes completion of the study procedures (MRI and 90-day follow-up assessment), including but not limited to life-expectancy less than 3 months, inability to lie flat, morbid obesity preventing use of MR and claustrophobia. - Patients with decompensated liver disease with ascites (since MRDTI evaluation will be inadequate in these patients)

Design outcomes

Primary

MeasureTime frame
To explore the diagnostic accuracy of MRDTI in the diagnostic management of acute and chronic SVT in a prospective diagnostic proof of concept study

Secondary

MeasureTime frame
1) To optimise MRDTI sequences for imaging SVT. 2) To assess the interobserver agreement of the readers of MRDTI for suspected SVT.

Contacts

Public ContactLisette van Dam
l.f.van_dam@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)