MRI for the Early Evaluation of Acute Intracerebral Hemorrhage

NCT ID: NCT01689402

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Cerebral Hemorrhage Intracranial Arteriovenous Malformations Intracranial Hemorrhage, Hypertensive Brain Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intracerebral Hemorrhage Patients

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

MRI Scan with the specified sequences below:

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hanne Christensen

Associate Research Professor, Consultant Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bispebjerg University Hospital

Copenhagen, Capital Region, Denmark

Site Status

Countries

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Denmark

References

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Sahni R, Weinberger J. Management of intracerebral hemorrhage. Vasc Health Risk Manag. 2007;3(5):701-9.

Reference Type BACKGROUND
PMID: 18078021 (View on PubMed)

Delgado Almandoz JE, Schaefer PW, Goldstein JN, Rosand J, Lev MH, Gonzalez RG, Romero JM. Practical scoring system for the identification of patients with intracerebral hemorrhage at highest risk of harboring an underlying vascular etiology: the Secondary Intracerebral Hemorrhage Score. AJNR Am J Neuroradiol. 2010 Oct;31(9):1653-60. doi: 10.3174/ajnr.A2156. Epub 2010 Jun 25.

Reference Type BACKGROUND
PMID: 20581068 (View on PubMed)

Wijman CA, Venkatasubramanian C, Bruins S, Fischbein N, Schwartz N. Utility of early MRI in the diagnosis and management of acute spontaneous intracerebral hemorrhage. Cerebrovasc Dis. 2010;30(5):456-63. doi: 10.1159/000316892. Epub 2010 Aug 24.

Reference Type BACKGROUND
PMID: 20733299 (View on PubMed)

Diedler J, Karpel-Massler G, Sykora M, Poli S, Sakowitz OW, Veltkamp R, Steiner T. Autoregulation and brain metabolism in the perihematomal region of spontaneous intracerebral hemorrhage: an observational pilot study. J Neurol Sci. 2010 Aug 15;295(1-2):16-22. doi: 10.1016/j.jns.2010.05.027. Epub 2010 Jun 16.

Reference Type BACKGROUND
PMID: 20557898 (View on PubMed)

Carhuapoma JR, Wang PY, Beauchamp NJ, Keyl PM, Hanley DF, Barker PB. Diffusion-weighted MRI and proton MR spectroscopic imaging in the study of secondary neuronal injury after intracerebral hemorrhage. Stroke. 2000 Mar;31(3):726-32. doi: 10.1161/01.str.31.3.726.

Reference Type BACKGROUND
PMID: 10700511 (View on PubMed)

Carhuapoma JR, Wang P, Beauchamp NJ, Hanley DF, Barker PB. Diffusion-perfusion MR evaluation and spectroscopy before and after surgical therapy for intracerebral hemorrhage. Neurocrit Care. 2005;2(1):23-7. doi: 10.1385/NCC:2:1:023.

Reference Type BACKGROUND
PMID: 16174964 (View on PubMed)

Karaszewski B, Thomas RG, Chappell FM, Armitage PA, Carpenter TK, Lymer GK, Dennis MS, Marshall I, Wardlaw JM. Brain choline concentration. Early quantitative marker of ischemia and infarct expansion? Neurology. 2010 Sep 7;75(10):850-6. doi: 10.1212/WNL.0b013e3181f11bf1.

Reference Type BACKGROUND
PMID: 20819997 (View on PubMed)

Other Identifiers

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H-2-2012-009

Identifier Type: -

Identifier Source: org_study_id

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