Acute diagnosis of large vessel occlusion (LVO) stroke for improving access toThrombectomy (Acronym: LVOCheck)Subproject: Optimization of sensitivity and specificity of a biomarker-based blood test

Recruiting

• Conditions: R55; I61; I62; E86; F44.4; Cerebral infarction; Occlusion and stenosis of cerebral arteries, not resulting in cerebral infarction; Epilepsy; Migraine; Hyperglycaemia, unspecified

• Registration Number: DRKS00030399
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

The study includes adult patients (18 years of age or older) who are suspected of having a stroke at the fire department dispatch center and to whom a STEMO is dispatched will be included in the study. Symptom onset must have occurred no more than 24 hours ago. Patients with Wake-Up Stroke will also be included in the study.

Exclusion Criteria

Patients who refuse to participate in the study or patients for whom blood sampling is not possible will not be included.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
As a primary study hypothesis, we postulate that the measurement of the two previously identified biomarkers FABP and NTproBNP in patients with acute stroke will allow the identification of patients with large vessel occlusion with a 98%-100% specificity and a sensitivity of at least 75%. Thus, sensitivity and specificity of the diagnostic algorithm investigated here represent the primary end point of the study.

Secondary Outcome Measures

Name	Time	Method
As secondary study hypotheses, we postulate that <br>- the quantification of the 2 previously identified biomarkers FABP and NTproBNP in patients with acute stroke is more sensitive in identifying patients with large vessel occlusion the more time has elapsed since the event. Thus, the change in sensitivity as a function of time elapsed since the event represents a secondary endpoint of the study.<br>- the main diagnosis of patients identified as false positives by the biomarker combination is ischemic cerebral infarction. The number of patients with ischemic cerebral infarction and false positive test relative to the number of all patients with false positive test thus represents a secondary endpoint.