NCT01689402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

5.1 years

First QC Date

September 18, 2012

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • early correct diagnosis of underlying vascular malformation

    Correct diagnosis based on findings on 8 weeks control MRI

    8 weeks

Study Arms (1)

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:

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • CT demonstrated ICH
  • Cardiopulmonary stable
  • Informed consent from patient or proxy
  • No General contraindication of MRI
  • Age above 18

You may not qualify if:

  • Lack of informed consent
  • lack of cooperability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg University Hospital

Copenhagen, Capital Region, DK-2400, Denmark

Location

Related Publications (7)

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

    PMID: 18078021BACKGROUND
  • 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.

    PMID: 20581068BACKGROUND
  • 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.

    PMID: 20733299BACKGROUND
  • 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.

    PMID: 20557898BACKGROUND
  • 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.

    PMID: 10700511BACKGROUND
  • 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.

    PMID: 16174964BACKGROUND
  • 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.

    PMID: 20819997BACKGROUND

MeSH Terms

Conditions

Cerebral HemorrhageIntracranial Arteriovenous MalformationsIntracranial Hemorrhage, HypertensiveBrain Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System Vascular MalformationsNervous System MalformationsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesIntracranial Arterial DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Professor, Consultant Neurologist

Study Record Dates

First Submitted

September 18, 2012

First Posted

September 21, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations