<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01689402</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2012-009</org_study_id>
    <nct_id>NCT01689402</nct_id>
  </id_info>
  <brief_title>MRI for the Early Evaluation of Acute Intracerebral Hemorrhage</brief_title>
  <official_title>MRI for Early Identification of Underlying Pathology in Patients With Acute Intracerebral Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      What happens in the borderzone of a cerebral hemorrhage remains widely onknown and furhter&#xD;
      the best timing for doing MR to look for vascular pathology in cerebral hemorrhage has not&#xD;
      yet been determined. In this study we do acute MRS, a non-invasive imaging mathod to detemine&#xD;
      the biochemsty in the border zone and structural MRI for vascular malformation. We repeat&#xD;
      structural MRI after 8 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study we want to investigate the ability of MRI to identify underlying pathology&#xD;
      (tumor or vascular malformations) in acute patients admitted with intracerebral hemorrhage&#xD;
      (ICH). Today MRI-scan is normally done 3-4 weeks after symptom onset but very little is known&#xD;
      about the early use of MRI to detect underlying pathology. This would allow an early&#xD;
      intervension and less uncertainty for the patients.&#xD;
&#xD;
      We further want to investigate the metabolic penumbra-zone surrounding the hematoma. It is&#xD;
      the current perception in the litterature that this zone represent a metabolic zone marked by&#xD;
      apoptosis and inflammation rather than ischemia.&#xD;
&#xD;
      We are planning to:&#xD;
&#xD;
      When patients arrive in our stroke department they will within 7 hours be subject to MRI scan&#xD;
      with the protocoled sequences. Standard sequences: Axial T2, axial DWI, Sagittal T1, T2 flair&#xD;
      og axial GRE-sequence.&#xD;
&#xD;
      Susceptibility weighted imaging (SWI)&#xD;
&#xD;
      Chemical Shift Imaging (CSI) multivoxel spectroscopi&#xD;
&#xD;
      Post contrast 3D box reconstruction&#xD;
&#xD;
      After 8 weeks the patients are subject to another MRI-Scan in accordance with the standard&#xD;
      clinical guideline to rule out underlying pathology.&#xD;
&#xD;
      After 3 month the patients are seen in the outpatient-clinic to follow-up evaluation.&#xD;
&#xD;
      To sum up the purpose of this present study is to conduct a pilot investigation of MRI in the&#xD;
      early evaluation of ICH-patients. Second it is our intension to use multivoxel magnetic&#xD;
      resonance spectroscopy to study the metabolic penumbra-zone surrounding the ICH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>early correct diagnosis of underlying vascular malformation</measure>
    <time_frame>8 weeks</time_frame>
    <description>Correct diagnosis based on findings on 8 weeks control MRI</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Cerebral Hemorrhage</condition>
  <condition>Intracranial Arteriovenous Malformations</condition>
  <condition>Intracranial Hemorrhage, Hypertensive</condition>
  <condition>Brain Neoplasms</condition>
  <arm_group>
    <arm_group_label>Intracerebral Hemorrhage Patients</arm_group_label>
    <description>Patients admitted with acute intracerebral hemorrhage within 72 hours after symptom onset.Patients are included in the study for MRI studies</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI Scan with the specified sequences below:</intervention_name>
    <description>Standard sequences: Axial T2, axial DWI, Sagittal T1, T2 flair og axial GRE-sequence.&#xD;
Susceptibility weighted imaging (SWI)&#xD;
Chemical Shift Imaging (CSI) multivoxel spectroscopi&#xD;
Post contrast 3D box reconstruction</description>
    <arm_group_label>Intracerebral Hemorrhage Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted with CT-demonstrated Intracerebral Hemorrhage (ICH) within 72 hours after&#xD;
        symptom onset.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CT demonstrated ICH&#xD;
&#xD;
          -  Cardiopulmonary stable&#xD;
&#xD;
          -  Informed consent from patient or proxy&#xD;
&#xD;
          -  No General contraindication of MRI&#xD;
&#xD;
          -  Age above 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent&#xD;
&#xD;
          -  lack of cooperability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bispebjerg University Hospital</name>
      <address>
        <city>Copenhagen</city>
        <state>Capital Region</state>
        <zip>DK-2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Sahni R, Weinberger J. Management of intracerebral hemorrhage. Vasc Health Risk Manag. 2007;3(5):701-9.</citation>
    <PMID>18078021</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20581068</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20733299</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20557898</PMID>
  </reference>
  <reference>
    <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. doi: 10.1161/01.str.31.3.726.</citation>
    <PMID>10700511</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16174964</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20819997</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Hanne Christensen</investigator_full_name>
    <investigator_title>Associate Research Professor, Consultant Neurologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Intracranial Hemorrhages</mesh_term>
    <mesh_term>Intracranial Arteriovenous Malformations</mesh_term>
    <mesh_term>Intracranial Hemorrhage, Hypertensive</mesh_term>
    <mesh_term>Arteriovenous Malformations</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01689402
org study id: H-2-2012-009
nct id: NCT01689402
lead sponsor: 
has dmc: No
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 model: Cohort
time perspective: Prospective
measure: early correct diagnosis of underlying vascular malformation
time frame: 8 weeks
description: Correct diagnosis based on findings on 8 weeks control MRI
arm group label: Intracerebral Hemorrhage Patients
description: Patients admitted with acute intracerebral hemorrhage within 72 hours after symptom onset.Patients are included in the study for MRI studies
intervention type: Device
intervention name: MRI Scan with the specified sequences below:
description: 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
arm group label: Intracerebral Hemorrhage Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
citation: Sahni R, Weinberger J. Management of intracerebral hemorrhage. Vasc Health Risk Manag. 2007;3(5):701-9.
PMID: 18078021
citation: 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: 20581068
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.
PMID: 20733299
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.
PMID: 20557898
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. doi: 10.1161/01.str.31.3.726.
PMID: 10700511
citation: 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: 16174964
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.
PMID: 20819997
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Hanne Christensen
investigator title: Associate Research Professor, Consultant Neurologist
mesh term: Brain Neoplasms
mesh term: Cerebral Hemorrhage
mesh term: Intracranial Hemorrhages
mesh term: Intracranial Arteriovenous Malformations
mesh term: Intracranial Hemorrhage, Hypertensive
mesh term: Arteriovenous Malformations
mesh term: Hemorrhage