MRI for the Early Evaluation of Acute Intracerebral Hemorrhage

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bispebjerg Hospital
Sponsor:
Information provided by (Responsible Party):
Hanne Christensen, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01689402
First received: September 18, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Cerebral Hemorrhage
Intracranial Arteriovenous Malformations
Intracranial Hemorrhage, Hypertensive
Brain Neoplasms
Device: MRI Scan with the specified sequences below:

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI for Early Identification of Underlying Pathology in Patients With Acute Intracerebral Hemorrhage

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • early correct diagnosis of underlying vascular malformation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Correct diagnosis based on findings on 8 weeks control MRI


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:

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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689402

Contacts
Contact: Hanne Christensen, MD, DMSci 004521729416 hchr0039@bbh.regionh.dk
Contact: Anders Christensen, MD, Ph.d achr0019@bbh.regionh.dk

Locations
Denmark
Bispebjerg University Hospital Recruiting
Copenhagen, Capital Region, Denmark, DK-2400
Contact: Hanne Christensen, MD, Ph.d, DMSci       hchr0039@bbh.regionh.dk   
Principal Investigator: Hanne Christensen, MD, Ph.d, DMSci         
Sub-Investigator: Anders F Christensen, MD, Ph.d         
Sponsors and Collaborators
Bispebjerg Hospital
  More Information

Publications:

Responsible Party: Hanne Christensen, Associate Research Professor, Consultant Neurologist, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01689402     History of Changes
Other Study ID Numbers: H-2-2012-009
Study First Received: September 18, 2012
Last Updated: July 15, 2014
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Intracranial Arteriovenous Malformations
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
Brain Neoplasms
Neoplasms
Hemorrhage
Intracranial Hemorrhages
Intracranial Hemorrhage, Hypertensive
Cerebral Hemorrhage
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014