MRI brain imaging in spontaneous intracerebral haemorrhage; pinpointing the underlying vascular disease

Recruiting

• Conditions: spontaneous intracerebral haemorrhage / brain bleeding; 10007963

• Registration Number: NL-OMON44852
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-31
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 221

Inclusion Criteria

For substudy A - 3T unenhanced MRI scanning:
- Age >= 18 years
- ICH confirmed by CT
- 3T MRI scanning possible preferably within 10 days, but at least within 3 months of ICH diagnosis
- No obvious cause of ICH (tumor, vascular anomaly or trauma as cause of haemorrhage);For substudy B - 7T gadolinium enhanced MRI scanning:
- Participants of substudy A
- 7T MRI scanning possible preferably within 10 days, but at least within 3 months of ICH diagnosis;For substudy C - CT spot sign study:
- Age >= 18 years
- ICH confirmed by CT
- CTP and CTA has been performed on admission
- Non contrast CT possible within 48 hours after symptom onset.
- No obvious cause of ICH (tumor, vascular anomaly or trauma as cause of haemorrhage)

Exclusion Criteria

For substudy A - 3T unenhanced MRI scanning:
- Contraindications for MR imaging (see appendix A research protocol) ;For substudy B - 7T gadolinium enhanced MRI scanning:
- Impossibility to undergo MRI (claustrophobia, implants or metal objects in or around the body).
- Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration.
- Severely impaired renal function (severe renal insufficiency, GFR <30 ml/min/1.73 m; or nephrogenic systemic fibrosis / nephrogenic fibrosing nefropathy (NSF/NDS))
- Pregnancy;For substudy C - CT spot sign study:
- Pregnancy ;For all studies:
- No informed consent obtained from patient or legal representative

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number and distribution of markers for brain and vascular abnormalities and on<br /><br>Magnetic Resonance Imaging (MRI).<br /><br>Number and characteristics of CTA spot sign and haematoma growth.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>