Diagnostic evaluation of Plasma GFAP for the rapid differentiation between Ischemic Stroke and Intracerebral Hemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Christian Medical College
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 1. Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of GFAP for differentiating patients with ICH from patients with ischemic stroke (including TIA) and stroke mimics.
Study Overview
Brief Summary
Stroke is the second most common cause of death globally.
To date, brain imaging is the gold standard for distinguishing patients with ischemic stroke and intracerebral hemorrhage, which requires hospital admittance of patients with symptoms suspicious for acute stroke and causes a tremendous time-to-treatment delay.
A rapid and reliable diagnostic test to distinguish ischemic from hemorrhagic stroke is essential to optimize management and triage for thrombolytic therapy.
Several studies conducted by Dr. Förch, a Neurologist in Germany, have shown that the brain-specific biomarker GFAP is released rapidly in acute ICH, whereas a more delayed release can be observed in patients with ischemic stroke.
Now it is important to replicate these findings in other populations as well. Based on the higher incidence rates in Asia and potential racial differences in GFAP release between Asian and Caucasian populations, the diagnostic accuracy of the GFAP testing need to be re-evaluated in a study performed in Asian countries.
This shall be done by testing the plasma concentration of GFAP of 200 patients admitted to CMC, Ludhiana with symptoms suspicious of acute stoke (targeting 80 patients with ICH and 120 patients with ischemic stroke or stroke mimics).
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Presence of neurological symptoms at hospital admission suspicious for acute stroke
- •Time interval from symptom onset to study inclusion < 12 h.
Exclusion Criteria
- •Ischemic stroke, intracerebral hemorrhage or transient ischemic attack within the last three months
- •Patients participating in other stroke trials/research
- •Known history of brain tumor at any time in patient history
- •Evidence for traumatic brain injury with the last 3 months
- •Participant in another stroke study
- •Informed consent not given.
Outcomes
Primary Outcomes
1. Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of GFAP for differentiating patients with ICH from patients with ischemic stroke (including TIA) and stroke mimics.
Time Frame: 1 month after the end of recruitment phase
2. Gold standard is the diagnosis of ICH, ischemic stroke (including TIA), or stroke mimic as determined at the end of hospital stay based on all available information.
Time Frame: 1 month after the end of recruitment phase
Secondary Outcomes
- 1. Analysis stratified for patients with a moderate to severe neurological deficit (NIHSS 9).(2. Analysis stratified for patients with different time windows (2 h, 2 to 6 h, 6 to 12 h) from symptom onset to blood withdrawal.)