Diagnostic Utility of MRI in Intracerebral Hemorrhage

NCT00363662 | Completed

• 1 other identifier: 2R01NS034866-08A1
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Diagnostic comparison

  Compare the diagnosis by the treating physician (based on the patient history, examination, CT, and angiography results) with the treating physician's diagnosis based on additional review of the MRI. The CT-based diagnosis and the MRI-based diagnosis by the treating physician will be compared to the "gold standard" diagnosis reached by the outside adjudication panel (which excludes information from the MRI studies).

  Approximately 60 minutes to acquire each scan.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory Albers, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 15, 2006
• Study Start: June 26, 2006
• Primary Completion: January 27, 2010
• Study Completion: January 27, 2010
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

US (1)