Diagnostic Utility of MRI in Intracerebral Hemorrhage
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Purpose
The overall aim of this project is to prospectively determine whether MRI can improve the conventional neuroradiological evaluation (CT with or without cerebral angiography) of patients with a spontaneous ICH or IVH. The study design will also allow us to identify the added benefit of specific MR sequences and repeat MRI in the chronic stage, thereby allowing us to prospectively determine their value in a consecutive series of patients. This information should have a major impact on the management of these patients by providing data on the diagnostic yield of routine MRI in patients presenting with a wide variety of causes for ICH or IVH. These data will help guide the diagnostic evaluation and the management of brain hemorrhage patients in the future.
| Condition |
|---|
|
Cerebral Hemorrhage |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Diagnostic Utility of MRI in Intracerebral Hemorrhage |
| Estimated Enrollment: | 160 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
A total of 180 ICH or IVH patients will be studied. All patients will be inpatients admitted to the Stanford Stroke Center, a multidisciplinary referral center for the treatment of acute stroke. Consecutive patients will be enrolled provided they meet the inclusion and exclusion criteria and that they or a legally authorized representative give informed consent.
Inclusion Criteria:
A. Men and non-pregnant women, at least 18 years of age.
B. Patients with an ICH or IVH admitted to Stanford University Medical center within 48 hours of symptom onset.
C. Ability to undergo MRI.
Exclusion Criteria:
A. Patients with a known (preexisting) source for ICH, for example a known untreated arterio-venous malformation.
B. Patients receiving investigational drug therapies or procedures prior to MRI scanning.
C. Glasgow coma scale (GCS) score < 6 in the absence of sedating medications.
D. Informed consent cannot be obtained either directly from the patient or from a legally authorized representative.
E. Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study
Contacts and Locations| Contact: Stephanie M Kemp, BS | (650) 723-4481 | skemp@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Stephanie M Kemp, BS 650-723-4481 skemp@stanford.edu | |
| Contact: Eyngorn, MD (650) 498-7333 ieyngorn@stanford.edu | |
| Principal Investigator: Christine Wijman | |
| Sub-Investigator: Gregory W Albers | |
| Sub-Investigator: Michael E. Moseley | |
| Sub-Investigator: Maarten G Lansberg MD, PhD | |
| Sub-Investigator: Anna K. Finley Caulfield | |
| Sub-Investigator: Neil Schwartz | |
| Sub-Investigator: Dr Marion S Buckwalter | |
| Sub-Investigator: Dr. chitra venkat | |
| Sub-Investigator: Waimei A Tai, MD | |
| Sub-Investigator: Jean Marc Olivot, MD | |
| Principal Investigator: | Christine Wijman | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00363662 History of Changes |
| Other Study ID Numbers: | 2 R01 NS034866-08A1 |
| Study First Received: | August 9, 2006 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hemorrhage Cerebral Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013