MRI for the Early Evaluation of Acute Intracerebral Hemorrhage

Brain Neoplasms Clinical Trial

Official title:

MRI for Early Identification of Underlying Pathology in Patients With Acute Intracerebral Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689402
• Other study ID #: H-2-2012-009
• Status: Completed
• Start date: April 2012
• Est. completion date: May 2017

Study information

• Verified date: January 2021
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Denmark	Bispebjerg University Hospital	Copenhagen	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. — View Citation

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. — View Citation

Delgado Almandoz JE, Schaefer PW, Goldstein JN, Rosand J, Lev MH, González 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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early correct diagnosis of underlying vascular malformation	Correct diagnosis based on findings on 8 weeks control MRI	8 weeks