MRI for the Early Evaluation of Acute Intracerebral Hemorrhage

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01689402
Collaborator
(none)
60
1
61
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MRI Scan with the specified sequences below:

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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
MRI for Early Identification of Underlying Pathology in Patients With Acute Intracerebral Hemorrhage
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Intracerebral Hemorrhage Patients

Patients admitted with acute intracerebral hemorrhage within 72 hours after symptom onset.Patients are included in the study for MRI studies

Device: MRI Scan with the specified sequences below:
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

Outcome Measures

Primary Outcome Measures

  1. early correct diagnosis of underlying vascular malformation [8 weeks]

    Correct diagnosis based on findings on 8 weeks control MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bispebjerg University Hospital Copenhagen Capital Region Denmark DK-2400

Sponsors and Collaborators

  • Bispebjerg Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hanne Christensen, Associate Research Professor, Consultant Neurologist, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01689402
Other Study ID Numbers:
  • H-2-2012-009
First Posted:
Sep 21, 2012
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021

Study Results

No Results Posted as of Jan 28, 2021