en
Scientific article
Open access
English

Optimization of sensitivity and specificity of a biomarker-based blood test (LVOCheck-Opti) : A protocol for a multicenter prospective observational study of patients suspected of having a stroke

Published inFrontiers in neurology, vol. 14, 1327348
Publication date2023
First online date2024-02-02
Abstract

Introduction: Acute ischemic stroke (AIS) is a time-critical medical emergency. For patients with large-vessel occlusions (LVO), mechanical thrombectomy (MT) is the gold-standard treatment. Mobile Stroke Units (MSUs) provide on-site diagnostic capabilities via computed tomography (CT) and have been shown to improve functional outcomes in stroke patients, but are cost-efficient only in urban areas. Blood biomarkers have recently emerged as possible alternative to cerebral imaging for LVO diagnosis. Prehospital LVO diagnosis offers the potential to transport patients directly to centers that have MT treatment available. In this study, we assess the accuracy of combining two biomarkers, HFABP and NT-proBNP, with clinical indicators to detect LVO using ultra-early prehospital blood samples. The study was registered in the German Clinical Trials Register (DRKS-ID: DRKS00030399).

Methods and analysis: We plan a multicenter prospective observational study with 800 patients with suspected stroke enrolled within 24 h of symptom onset. Study participants will be recruited at three sites (MSUs) in Berlin, Germany. Blood-samples will be taken pre-hospitally at the scene and tested for HFABP and NT-proBNP levels. Additional clinical data and information on final diagnosis will be collected and documented in an electronic case report form (eCRF). Sensitivity and specificity of the combination will be calculated through iterative permutation-response calculations.

Discussion: This study aims to evaluate the diagnostic capabilities of a combination of the biomarkers HFABP and NT-proBNP in LVO prediction. In contrast to most other biomarker studies to date, by employing MSUs as study centers, ultra-early levels of biomarkers can be analyzed. Point-of-care LVO detection in suspected stroke could lead to faster treatment in both urban and rural settings and thus improve functional outcomes on a broader scale.

Clinical trial registration: Deutsches Register klinischer Studien https://drks.de/search/de/trial/DRKS00030399, DRKS00030399.

eng
Keywords
  • Biomarkers
  • Cerebrovascular disease
  • Emergency medicine
  • Large vessel occlusion
  • Mobile stroke units
  • Prehospital emergency medicine
  • Stroke
  • Stroke mimics
Citation (ISO format)
KAFFES, Maximilian et al. Optimization of sensitivity and specificity of a biomarker-based blood test (LVOCheck-Opti) : A protocol for a multicenter prospective observational study of patients suspected of having a stroke. In: Frontiers in neurology, 2023, vol. 14, p. 1327348. doi: 10.3389/fneur.2023.1327348
Main files (1)
Article (Published version)
Identifiers
ISSN of the journal1664-2295
11views
2downloads

Technical informations

Creation02/19/2024 4:11:06 PM
First validation04/24/2024 3:43:12 PM
Update time04/24/2024 3:43:12 PM
Status update04/24/2024 3:43:12 PM
Last indexation05/06/2024 6:27:56 PM
All rights reserved by Archive ouverte UNIGE and the University of GenevaunigeBlack