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MRI for the Early Evaluation of Acute Intracerebral Hemorrhage

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bispebjerg Hospital
Sponsor:
Information provided by (Responsible Party):
Hanne Christensen, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01689402
First received: September 18, 2012
Last updated: July 15, 2014
Last verified: July 2014

September 18, 2012
July 15, 2014
April 2012
April 2015   (final data collection date for primary outcome measure)
early correct diagnosis of underlying vascular malformation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Correct diagnosis based on findings on 8 weeks control MRI
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Complete list of historical versions of study NCT01689402 on ClinicalTrials.gov Archive Site
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MRI for the Early Evaluation of Acute Intracerebral Hemorrhage
MRI for Early Identification of Underlying Pathology in Patients With Acute Intracerebral Hemorrhage

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients admitted with CT-demonstrated Intracerebral Hemorrhage (ICH) within 72 hours after symptom onset.

  • Cerebral Hemorrhage
  • Intracranial Arteriovenous Malformations
  • Intracranial Hemorrhage, Hypertensive
  • Brain Neoplasms
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

Intracerebral Hemorrhage Patients
Patients admitted with acute intracerebral hemorrhage within 72 hours after symptom onset.Patients are included in the study for MRI studies
Intervention: Device: MRI Scan with the specified sequences below:

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
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April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Hanne Christensen, MD, DMSci 004521729416 hchr0039@bbh.regionh.dk
Contact: Anders Christensen, MD, Ph.d achr0019@bbh.regionh.dk
Denmark
 
NCT01689402
H-2-2012-009
No
Hanne Christensen, Bispebjerg Hospital
Bispebjerg Hospital
Not Provided
Not Provided
Bispebjerg Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP