Clinical trial NCT00206908: BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)
Official title: BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Stroke Mimic(Conditions Presenting With Stroke-like Conditions)
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cerebral ischemia or intracranial hemorrhage suspected.

Brief 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.

Detailed 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.

Eligibility criteria: 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:

None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Neurological Institute
state: Alabama
city: Los Angeles
country: United States
facility: University of California, Los Angeles Medical Center
state: California
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: Denver
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Louisville
country: United States
facility: Kentucky Neuroscience Research
state: Kentucky
city: Worcester
country: United States
facility: University of Massachusettes, Worcester Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Lansing
country: United States
facility: Ingham Regional Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Henepin County Medical Center
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Health System
state: Missouri
city: Durham
country: United States
facility: Duke University Hopsital
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Heidelberg
country: Germany
facility: Neurologische Universitatsklinik/Heidelberg
city: Lausanne
country: Switzerland
facility: CHUV-Lausanne
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: Duke University Hospital
name: Daniel Laskowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: