- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01689402
MRI for the Early Evaluation of Acute Intracerebral Hemorrhage
MRI for Early Identification of Underlying Pathology in Patients With Acute Intracerebral Hemorrhage
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Capital Region
-
Copenhagen, Capital Region, Denmark, DK-2400
- Bispebjerg University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intracerebral Hemorrhage Patients
Patients admitted with acute intracerebral hemorrhage within 72 hours after symptom onset.Patients are included in the study for MRI studies
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
early correct diagnosis of underlying vascular malformation
Time Frame: 8 weeks
|
Correct diagnosis based on findings on 8 weeks control MRI
|
8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Sahni R, Weinberger J. Management of intracerebral hemorrhage. Vasc Health Risk Manag. 2007;3(5):701-9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Congenital Abnormalities
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Cardiovascular Abnormalities
- Nervous System Malformations
- Vascular Malformations
- Intracranial Arterial Diseases
- Central Nervous System Vascular Malformations
- Hemorrhage
- Brain Neoplasms
- Arteriovenous Malformations
- Intracranial Hemorrhages
- Cerebral Hemorrhage
- Intracranial Arteriovenous Malformations
- Intracranial Hemorrhage, Hypertensive
Other Study ID Numbers
- H-2-2012-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Neoplasms
-
National Cancer Institute (NCI)CompletedBrain Cancer | Brain Neoplasm | Brain Tumor, PrimaryUnited States
-
Constantinos HadjipanayisNational Cancer Institute (NCI); NX PharmaGenWithdrawnGlioblastoma | Brain Cancer | Brain Tumors | Brain Tumor, Recurrent | Benign Neoplasms, Brain | Brain Neoplasms, Benign | Brain Neoplasms, Malignant | Brain Tumor, Primary | Intracranial Neoplasms | Neoplasms, Brain | Neoplasms, Intracranial | Primary Brain Neoplasms | Primary Malignant Brain Neoplasms | Primary Malignant... and other conditionsUnited States
-
Vanderbilt University Medical CenterUniversity of Alabama at Birmingham; Emory University; H. Lee Moffitt Cancer... and other collaboratorsTerminatedBrain Neoplasms, Benign | Brain Neoplasms, Malignant | Brain Neoplasm, PrimaryUnited States
-
BioNumerik Pharmaceuticals, Inc.Crown BioscienceCompletedBrain Neoplasms | Brain Tumors | Malignant Neoplasms, BrainUnited States
-
University of Erlangen-Nürnberg Medical SchoolNot yet recruitingBrain Tumor, Primary | Brain Tumor - MetastaticGermany
-
National Cancer Institute (NCI)TerminatedCentral Nervous System Neoplasms | Brain Cancer | Neoplasms, Brain | Primary Brain Neoplasms | Cancer of the BrainUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedBrain Stem Neoplasms, Primary | Neoplasms, Brain StemUnited States
-
Lawson Health Research InstituteCompletedBrain Tumor | Brain Neoplasm | Tumor, Brain | Neoplasm, Supratentorial | Tumor, SupratentorialCanada
-
University of NebraskaRecruitingPrimary Brain Tumor | Metastatic Brain TumorUnited States
-
Mayo ClinicRecruitingBrain Tumor | Brain Tumor Adult | Brain LesionUnited States
Clinical Trials on MRI Scan with the specified sequences below:
-
Medtronic Cardiac Rhythm and Heart FailureCompletedImplantable DefibrillatorSaudi Arabia, United States, Hong Kong, Switzerland, Sweden, Canada, Germany, Netherlands, Belgium, Hungary, India, Chile, Italy
-
Medtronic Cardiac Rhythm and Heart FailureCompletedCardiac Pacing | Magnetic Resonance Imaging (MRI)Saudi Arabia, Taiwan, Switzerland, Hong Kong, India, Germany, Australia, Portugal, Serbia, Austria, Belgium, Chile, China, Colombia, Netherlands, Singapore, Slovakia, South Africa, Spain
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisNational Cancer Institute, France; Ligue contre le cancer, France; Fondation ARCRecruitingPancreatic CancerFrance
-
San Francisco Veterans Affairs Medical CenterUniversity of California, San Francisco; Bayer Healthcare Pharmaceuticals,...UnknownHepatocellular CarcinomaUnited States
-
Assistance Publique Hopitaux De MarseilleTerminated
-
ReFlow Medical, Inc.Massachusetts General Hospital; Syntropic CorelabCompletedCritical Limb IschemiaDominican Republic
-
NYU Langone HealthWithdrawn
-
Centre Hospitalier Universitaire de NīmesWithdrawnAlzheimer Disease | Amyloid Cerebral AngiopathyFrance
-
Eric A. HoffmanCompleted