NCT07277790

Brief Summary

The Cincinnati Prehospital Stroke Scale (CPSS) is traditionally scored directly by a healthcare professional or a layperson who independently observes facial droop, arm weakness, and speech disturbance, constituting the primary CPSS score. In contrast, this study focuses on witness-derived secondary CPSS scoring, which is performed indirectly by an emergency physician who is blinded to the patient's physical examination findings and relies exclusively on symptom descriptions provided by witnesses of the patient's initial presentation. This prospective analytical cross-sectional study aims to evaluate the predictive accuracy of secondary CPSS scores obtained by emergency physicians through structured interviews with witnesses of suspected stroke cases. Interrater reliability will be assessed between secondary CPSS scores independently assigned by a senior emergency medicine resident and an attending emergency physician based on witness-reported symptom descriptions. Secondary CPSS scores will then be compared with final neuroimaging diagnoses (CT/MRI), which will serve as the diagnostic gold standard. The study will also investigate the association between physician-coded secondary CPSS scores, witness demographic characteristics, and delays in seeking emergency medical care. Research Questions

  1. 1.Are witness-derived secondary CPSS scores, as assigned by an emergency physician, a valid tool for predicting ischemic stroke?
  2. 2.Are witness-derived secondary CPSS scores of ≥1 associated with shorter recognition-to-action time (decision delay)?
  3. 3.Witness-derived secondary CPSS scores assigned by an emergency physician are a valid diagnostic tool for predicting ischemic stroke.
  4. 4.Witness-derived secondary CPSS scores of ≥1 are associated with shorter recognition-to-action time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 19, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 29, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

Cincinnati Prehospital Stroke ScaleWitness-Derived CPSSStroke WitnessDecision DelayEmergency MedicinePredictive Validity

Outcome Measures

Primary Outcomes (2)

  • Secondary CPSS Score

    Defined as the score indirectly derived from witness reports by an emergency physician who was blinded to the patient's physical examination and relied on the observations of individuals who witnessed the patient's initial symptoms. Physician-coded CPSS score derived from structured witness face-to-face interviews; assessed as a continuous variable (0-3) and dichotomized (≥1 vs 0).

    During ED admission interview

  • Final Diagnosis

    Final diagnosis categorized as ischemic stroke, hemorrhagic stroke, or non-stroke, based on CT and/or MRI reports interpreted by independent radiologists.

    At completion of diagnostic evaluation (ED visit)

Secondary Outcomes (2)

  • Decision Delay

    Reported by the witness at ED arrival

  • Witness Demographic Characteristics

    Reported by the witness at ED arrival

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population was stroke witnesses (family members, friends, neighbors, or bystanders) who observed the patient's initial symptoms and accompanied the patient to the emergency department with acute suspected stroke symptoms.

You may qualify if:

  • Age ≥18 years
  • Witnessing onset/discovery of stroke-like symptoms
  • Accompanying the patient to the ED
  • Being the individual who decided to call EMS or arrange transport
  • No cognitive impairment affecting communication
  • Not a healthcare professional
  • Patient requiring advanced neuroimaging (CT/MRI)
  • Provided written informed consent

You may not qualify if:

  • Age \<18 years
  • Did not witness symptoms
  • Cognitive impairment limiting communication
  • Did not make the action decision
  • Healthcare professionals
  • Patients transferred with pre-confirmed stroke
  • Lack of consent or withdrawal
  • Missing/incomplete CPSS scoring items

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University, Faculty of Medicine, Ankara Bilkent City Hospital, Department of Emergency Medicine

Çankaya, Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (2)

  • De Luca A, Giorgi Rossi P, Villa GF; Stroke group Italian Society pre hospital emergency Services. The use of Cincinnati Prehospital Stroke Scale during telephone dispatch interview increases the accuracy in identifying stroke and transient ischemic attack symptoms. BMC Health Serv Res. 2013 Dec 11;13:513. doi: 10.1186/1472-6963-13-513.

  • Chiquete E, Sandoval-Rodriguez V, Garcia-Grimshaw M, Jimenez-Ruiz A, Gomez-Pina JJ, Ruiz-Ruiz E, Ramirez-Garcia G, Flores-Silva F, Cantu-Brito C, Ochoa-Guzman A, Ruiz-Sandoval JL. Reliability of Bystander Recognition of Clinical Features in Pre-Hospital Classification of Acute Cerebrovascular Syndromes: Preliminary Findings. Rev Invest Clin. 2020 May 7;73(2):87-93. doi: 10.24875/RIC.20000238.

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • Betül Akbuğa Özel

    Ankara Bilkent City Hospital, Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 11, 2025

Study Start

August 15, 2025

Primary Completion

November 15, 2025

Study Completion

November 22, 2025

Last Updated

December 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

De-identified dataset will be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of the main results.
Access Criteria
Academic researchers upon request to the corresponding author.

Locations