Diagnostic Utility of MRI in Intracerebral Hemorrhage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00363662
First received: August 9, 2006
Last updated: June 12, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Stanford University:

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
Study Population

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.

Criteria

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
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: NCT00363662

Contacts
Contact: Stephanie M Kemp, BS (650) 723-4481 skemp@stanford.edu

Locations
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         
Sponsors and Collaborators
Stanford University
Investigators
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 August 28, 2014