DIagnostic AngioGRAphy to find vascular Malformations (DIAGRAM study) in patients with spontaneous intracerebral haemorrhage
Completed
- Conditions
- intracerebral haemorrhagestroke10007963
- Registration Number
- NL-OMON39633
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with spontaneous intracerebral haemorrhage (ICH) between 18 and 70 years of age.
Exclusion Criteria
Patients between 45 and 70 years with a known history of hypertension and ICH in the thalamus, putamen, or posterior fossa will be excluded, as well as patients on oral anticoagulants with an INR greater than 2.5 and patients who will not be able to undergo (one of) the examinations because of contraindications.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome will be the detection of a vascular malformation with a<br /><br>(combination of) test(s) as expressed by means of the area under the receiver<br /><br>operator characteristic curve.<br /><br>Using a logistic regression model we will assess which (combination of) test(s)<br /><br>discerns best between presence and absence of a vascular malformation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome will be the effectiveness of the diagnostic tests,<br /><br>separately and in combination, expressed as remaining life expectancy in good<br /><br>health (independent) and the number of quality-adjusted lifeyears (QALY*s).</p><br>