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Stroke (CVA) or Transient Ischemic AttackNCT07277790

Predictive Value of Witness-derived Secondary Cincinnati Prehospital Stroke Scale Scores in Suspected Stroke

An observational study of Stroke (CVA) or Transient Ischemic Attack, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
235 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Aug 2025to 22 Nov 2025
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Yıldırım Beyazıt University, Faculty of Medicine, Ankara Bilkent City Hospital, Department of Emergency Medicine

    Çankaya, Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Predictive Value of Emergency Physician-coded Cincinnati Prehospital Stroke Scale Scores Based on Witness Reports and Their Association With Action Decision Time: A Cross-sectional Emergency Department Validation Study

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.

Read more

Research Questions

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

Research Hypotheses

  1. Witness-derived secondary CPSS scores assigned by an emergency physician are a valid diagnostic tool for predicting ischemic stroke.
  2. Witness-derived secondary CPSS scores of ≥1 are associated with shorter recognition-to-action time.

A total of 235 stroke witnesses, including family members, friends, neighbors, or bystanders who observed the patient's initial symptoms and accompanied the patient to the emergency department with acute stroke or stroke-like symptoms, will be included. All eligible participants will provide written informed consent prior to enrollment. Witnesses will undergo a structured, physician-administered interview in which they will be asked to recall and describe the patient's first symptoms. Based solely on these reports, an emergency physician blinded to the patient's clinical examination will assign a secondary CPSS score focusing on facial droop, arm weakness, and speech impairment. Two investigators will independently score the secondary CPSS to enable interrater agreement analysis.

Participants will also provide demographic data and report three key time points: symptom recognition, decision to seek care, and arrival at the emergency department. These data will be used to calculate onset-to-door time (prehospital delay), recognition-to-action time (decision delay), and call-to-door time (transfer delay). Data collection and emergency care provision will be conducted by investigators independent of those performing secondary CPSS scoring to minimize bias.

Read the detailed description

Study Design

  • Prospective, analytical, cross-sectional validation study
  • Conducted in the Emergency Department of a tertiary academic hospital in Türkiye Two phases
  1. Phase 1: Interrater reliability assessment: Between a senior emergency medicine (EM) resident and an emergency medicine (EM) attending physician
  2. Phase 2:

Predictive validity assessment The association between secondary CPSS scores, witness demographic characteristics, and decision delays

Phase 1:

Inter-rater agreement between a senior EM resident and an EM attending was assessed using CPSS scoring based on the same witness reports. All witness interviews were conducted face-to-face by trained emergency physicians during the initial ED evaluation. Independent, blinded scoring was performed using CPSS items (0-3 points). Agreement was quantified through percent agreement and Cohen's κ statistics.

Phase 2:

Secondary CPSS scores were compared to final radiological diagnoses. This study investigates the usability and clinical value of witness-derived CPSS scoring through structured interviews conducted by emergency physicians. Given that witnesses are often the first observers of neurological deficits, their descriptions may play a substantial role in early stroke recognition. Recognition-to-action time (decision delay) was obtained from structured witness questionnaires. Witness demographics were recorded.

Data collection used two research forms (RF: RF-1 for reliability assessment; RF-2 for BT/MRI result, witness characteristics and decision delay). All CT/MRI interpretations were performed by independent radiologists. Data were anonymized, coded (HY1, HY2…), and entered daily into SPSS by a research assistant.

Missing or ambiguous time data were clarified during interviews; incomplete CPSS items were excluded. Bias was minimized through consecutive sampling, standardized training, blinding procedures, and a controlled interview environment.

The study follows STROBE guidelines.

Study definitions This section outlines the key terms and operational definitions used throughout the study.

Witness or bystander: Defined as the individual who was with the patient at symptom onset, discovered the patient, or was contacted by the patient.

Onset-to-door time: Defined as the interval from the onset of the patient's symptoms to arrival at the emergency department. Onset-to-door time (ODT) consists of the recognition-to-action time (RAT), determined by the patient experiencing the event or by the stroke witness, and the call-to-door time (CDT), determined by emergency medical services teams. [ODT = RAT + CDT].

Recognition-to-action time: The secondary objectives of this study focus on the recognition-to-action time as determined by the stroke witness. During this interval, the witness undergoes several sequential decision-making processes. Recognizing the suspected stroke symptom(s) constitutes the first decision mechanism; assessing the seriousness of the situation represents the second; inferring whether the condition may be a stroke is the third; deciding whether to call an ambulance or transport the patient to the emergency department is the fourth; and finally, initiating the act of calling EMS-transitioning from decision to behavior-represents the combined decision and action mechanism.

Because, in practice, it is difficult to draw sharp boundaries among these sequential, decision-driven intervals, the time between recognition and taking action was evaluated as a single combined measure in this study. Witnesses were first asked to report the time at which they initially noticed the symptoms, and then the time at which they took action to call an EMS ambulance or transport the patient to the emergency department. The difference between these two time points was defined as the recognition-to-action time.

Delay: In this study, the term prehospital delay (PD) is used to describe delays occurring within the onset-to-door period. Delays within this recognition-to-action interval were referred to as decision delay (DD). The term transfer delay (TD) is used to describe delays occurring within the call-to-door interval. [PD = DD + TD].

Primary CPSS score: Defined as the score obtained directly from the healthcare professional or the layperson (patient or witness), who independently observes the patient's facial droop, arm weakness, and speech using the scale.

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.

Keywords
Cincinnati Prehospital Stroke Scale, Witness-Derived CPSS, Stroke Witness, Decision Delay, Emergency Medicine, Predictive Validity
Medical subject headings
Stroke, Ischemic Attack, Transient

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: During ED admission interview

  2. Final Diagnosis

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

    Measured: At completion of diagnostic evaluation (ED visit)

Secondary outcomes (2)
  1. Decision Delay

    The difference between the time at which witness first noticed or recognized the suspected stroke symptoms and the time at which he took action to call an EMS ambulance or transport the patient to the emergency department. Analyzed as:

    • Continuous variable (minutes)
    • Categorical: <30 min vs ≥30 min

    Measured: Reported by the witness at ED arrival

  2. Witness Demographic Characteristics

    Age, gender, education, employment, relationship to patient; analyzed for association with decision delay and secondary CPSS score

    Measured: Reported by the witness at ED arrival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start15 Aug 2025
  3. Primary completion15 Nov 2025
  4. Study completion22 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07277790
Sponsor's protocol ID
TABED 1-25-1588
Status last verified
Nov 2025
First submitted
29 Nov 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified dataset will be shared upon reasonable request.

Publications

  • 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.

    PubMed 24330761
  • 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.

    PubMed 33057320

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