MRI for the Early Evaluation of Acute Intracerebral Hemorrhage
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01689402 |
|
Recruitment Status
: Unknown
Verified July 2014 by Hanne Christensen, Bispebjerg Hospital.
Recruitment status was: Recruiting
First Posted
: September 21, 2012
Last Update Posted
: July 16, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Cerebral Hemorrhage Intracranial Arteriovenous Malformations Intracranial Hemorrhage, Hypertensive Brain Neoplasms | Device: MRI Scan with the specified sequences below: |
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 : | Observational |
| Estimated Enrollment : | 60 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | MRI for Early Identification of Underlying Pathology in Patients With Acute Intracerebral Hemorrhage |
| Study Start Date : | April 2012 |
| Estimated Primary Completion Date : | April 2015 |
| 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
|
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 |
- early correct diagnosis of underlying vascular malformation [ Time Frame: 8 weeks ]Correct diagnosis based on findings on 8 weeks control MRI
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689402
| Contact: Hanne Christensen, MD, DMSci | 004521729416 | hchr0039@bbh.regionh.dk | |
| Contact: Anders Christensen, MD, Ph.d | achr0019@bbh.regionh.dk |
| 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 | |
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 |
| First Posted: | September 21, 2012 Key Record Dates |
| Last Update Posted: | July 16, 2014 |
| Last Verified: | July 2014 |
Additional relevant MeSH terms:
|
Cerebral Hemorrhage Hemorrhage Congenital Abnormalities Brain Neoplasms Intracranial Hemorrhages Arteriovenous Malformations Hemangioma Intracranial Arteriovenous Malformations Intracranial Hemorrhage, Hypertensive Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Vascular Malformations Cardiovascular Abnormalities Neoplasms, Vascular Tissue Neoplasms by Histologic Type Central Nervous System Vascular Malformations Nervous System Malformations Intracranial Arterial Diseases |