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MRI for the Early Evaluation of Acute Intracerebral Hemorrhage

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ClinicalTrials.gov Identifier: NCT01689402
Recruitment Status : Unknown
Verified July 2014 by Hanne Christensen, Bispebjerg Hospital.
Recruitment status was:  Recruiting
First Posted : September 21, 2012
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):

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
Cerebral Hemorrhage Intracranial Arteriovenous Malformations Intracranial Hemorrhage, Hypertensive Brain Neoplasms 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
Estimated 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 : April 2012
Estimated Primary Completion Date : April 2015


Groups and Cohorts

Group/Cohort 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 [ Time Frame: 8 weeks ]
    Correct diagnosis based on findings on 8 weeks control MRI


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted with CT-demonstrated Intracerebral Hemorrhage (ICH) within 72 hours after symptom onset.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689402


Contacts
Contact: Hanne Christensen, MD, DMSci 004521729416 hchr0039@bbh.regionh.dk
Contact: Anders Christensen, MD, Ph.d achr0019@bbh.regionh.dk

Locations
Denmark
Bispebjerg University Hospital Recruiting
Copenhagen, Capital Region, Denmark, DK-2400
Contact: Hanne Christensen, MD, Ph.d, DMSci       hchr0039@bbh.regionh.dk   
Principal Investigator: Hanne Christensen, MD, Ph.d, DMSci         
Sub-Investigator: Anders F Christensen, MD, Ph.d         
Sponsors and Collaborators
Bispebjerg Hospital
More Information

Publications:

Responsible Party: Hanne Christensen, Associate Research Professor, Consultant Neurologist, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01689402     History of Changes
Other Study ID Numbers: H-2-2012-009
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Hemorrhage
Congenital Abnormalities
Cerebral Hemorrhage
Brain Neoplasms
Intracranial Hemorrhages
Arteriovenous Malformations
Hemangioma
Intracranial Arteriovenous Malformations
Intracranial Hemorrhage, Hypertensive
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Vascular Malformations
Cardiovascular Abnormalities
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases