BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)

Stroke Clinical Trial

Official title:

BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206908
• Other study ID #: 003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: July 20, 2015
• Start date: July 2002

Study information

• Verified date: July 2015
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This project is designed to evaluate the clinical utility of a novel blood test, the Triage Stroke Panel, as an aid in the diagnosis and assessment of stroke. The Triage Stroke Panel test device, used with the Triage MeterPlus, is a rapid, point-of-care immunoassay. The test measures the concentration of various analytes present in EDTA-anticoagulated whole blood or plasma, specifically B-type natriuretic peptide (BNP), fibrin degradation products containing D-Dimer, matrix metalloproteiase-9 (MMP-9), and S-100B. The test utilizes a proprietary algorithm for the automatic calculation of a single Multimarker Index (MMX) result from the individual biomarker values. The MMX result is being evaluated for use as an aid in the assessment and diagnosis of stroke.

Description:

To date, there is no commercially available blood test approved in the United States for use as an aid in the assessment and diagnosis of stroke. There have been various reports in the scientific literature describing the ability of various biomarkers to predict or identify stroke, with varied success. A biomarker panel approach, similar to that used for the evaluation of chest pain patients (troponin I, CK-MB, and myoglobin) enhances diagnostic accuracy, particularly when the panel includes protein markers associated with various components of the disease pathophysiology. This study involves a retrospective analysis of data collected from patients that present with an acute focal neurological deficit, suspected cerebral ischemia, or suspected intracranial hemorrhage within 24 hours of symptom onset or last known well time will be enrolled into the study. Blood samples will be collected at enrollment and serially up to 72 hrs. from the time of onset or last known well time. The study population will also include a subset of patients with subarachnoid hemorrhage, who will have additional samples collected daily from day 3 through day 14 (at clinical sites participating in the vasospasm substudy) for the evaluation of cerebral vasospasm. The patient's participation in the study is complete when all samples have been collected or when they are discharged from the hospital, whichever occurs first. All blood sample will be analyzed using the Triage Stroke Panel test. Measurements will be performed at each clinical site and at Biosite (subject to test device availability). In order to minimize bias and eliminate significant risk to the patient, physicians will be blinded to all Triage Stroke Panel results during the course of the study. Completed case report forms (CRFs) and frozen plasma samples will be transferred to Biosite.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age 18 and above Cerebral ischemia or intracranial hemorrhage suspected Enrollment within 24 hrs from symptom onset or last well-known time

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Stroke
• Stroke Mimic(Conditions Presenting With Stroke-like Conditions)

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario
Germany	Neurologische Universitatsklinik/Heidelberg	Heidelberg
Switzerland	CHUV-Lausanne	Lausanne
United Kingdom	University of Nottingham	Nottingham
United States	Alabama Neurological Institute	Birmingham	Alabama
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Denver Health	Denver	Colorado
United States	University of Colorado Health Science Center	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Hopsital	Durham	North Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	St. Luke's Health System	Kansas City	Missouri
United States	Ingham Regional Medical Center	Lansing	Michigan
United States	University of California, Los Angeles Medical Center	Los Angeles	California
United States	Kentucky Neuroscience Research	Louisville	Kentucky
United States	Henepin County Medical Center	Minneapolis	Minnesota
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Hospital at the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Massachusettes, Worcester Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Switzerland,  United Kingdom,