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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030399

Enrollment

800

Registered

2022-12-27

Start date

2023-01-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I63 I66 G40 G43 R73.9 N39.0 R55 I61 I62 E86 F44.4

Interventions

Group 1: Prehospital patients treated by one of the three Berlin STEMOs with suspected stroke

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
As secondary study hypotheses, we postulate that - 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. - 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.	—

Measure

Time frame

As secondary study hypotheses, we postulate that - 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. - 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.

—

Countries

Germany

Contacts

Public ContactJoachim Weber

Charité - Universitätsmedizin Berlin

joachim.weber@bih-charite.de(030) 450 543 524

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026