MRI for the Early Evaluation of Acute Intracerebral Hemorrhage

Completed

• Conditions: Intracranial Arteriovenous Malformations; Brain Neoplasms; Cerebral Hemorrhage; Intracranial Hemorrhage, Hypertensive

• Registration Number: NCT01689402
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

What happens in the borderzone of a cerebral hemorrhage remains widely onknown and furhter the best timing for doing MR to look for vascular pathology in cerebral hemorrhage has not yet been determined. In this study we do acute MRS, a non-invasive imaging mathod to detemine the biochemsty in the border zone and structural MRI for vascular malformation. We repeat structural MRI after 8 weeks.

Detailed Description

In this study we want to investigate the ability of MRI to identify underlying pathology (tumor or vascular malformations) in acute patients admitted with intracerebral hemorrhage (ICH). Today MRI-scan is normally done 3-4 weeks after symptom onset but very little is known about the early use of MRI to detect underlying pathology. This would allow an early intervension and less uncertainty for the patients.

We further want to investigate the metabolic penumbra-zone surrounding the hematoma. It is the current perception in the litterature that this zone represent a metabolic zone marked by apoptosis and inflammation rather than ischemia.

We are planning to:

When patients arrive in our stroke department they will within 7 hours be subject to MRI scan with the protocoled sequences. Standard sequences: Axial T2, axial DWI, Sagittal T1, T2 flair og axial GRE-sequence.

Susceptibility weighted imaging (SWI)

Chemical Shift Imaging (CSI) multivoxel spectroscopi

Post contrast 3D box reconstruction

After 8 weeks the patients are subject to another MRI-Scan in accordance with the standard clinical guideline to rule out underlying pathology.

After 3 month the patients are seen in the outpatient-clinic to follow-up evaluation.

To sum up the purpose of this present study is to conduct a pilot investigation of MRI in the early evaluation of ICH-patients. Second it is our intension to use multivoxel magnetic resonance spectroscopy to study the metabolic penumbra-zone surrounding the ICH.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• CT demonstrated ICH
• Cardiopulmonary stable
• Informed consent from patient or proxy
• No General contraindication of MRI
• Age above 18

Exclusion Criteria

• Lack of informed consent
• lack of cooperability

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
early correct diagnosis of underlying vascular malformation	8 weeks	Correct diagnosis based on findings on 8 weeks control MRI

Trial Locations

Locations (1)

Bispebjerg University Hospital; 🇩🇰 Copenhagen, Capital Region, Denmark