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Impact of Presenting Symptoms on Treatment Time and Outcomes in Acute Ischemic Stroke

5. august 2026 oppdatert av: Ahmad Ramadan Abdelazeem Saleh, Assiut University

Impact of Presenting Symptoms in Ischemic Stroke Onset on Time Treatment Window and Clinical Outcome of Acute Ischemic Stroke Patients

This observational study aims to understand how the specific symptoms a person experiences at the start of an acute ischemic stroke affect how quickly they receive treatment and how well they recover.

In stroke care, rapid treatment is critical because delayed intervention can lead to more severe disability or death. Patients who experience "high urgency" or classic stroke symptoms, such as sudden paralysis, severe facial drooping, or loss of speech, tend to arrive at the emergency room very quickly because these signs are easily recognized by bystanders. In contrast, patients who experience "low urgency" or vague symptoms, such as dizziness, numbness, visual changes, or a new-onset headache, often delay seeking medical care. Because these vague symptoms can mimic other medical conditions, they can lead to delayed diagnosis and longer waiting times for specific stroke treatments.

The researchers will observe 120 adult patients admitted for a first-ever acute ischemic stroke. Participants will be categorized into two groups based on whether their initial stroke symptoms were highly urgent or vague. The study will track and compare both groups to evaluate:

  • The time it takes for patients to arrive at the hospital and receive intervention therapies.
  • The patients' level of physical disability and independence in daily activities.
  • The patients' cognitive function.
  • The total length of the hospital stay, complication rates, and overall survival. Participants will be monitored from the time of their hospital admission through their discharge. To measure long-term recovery and functional outcomes, patients will also complete follow-up assessments at two weeks, one month, two months, and three months after leaving the hospital.

Studieoversikt

Status

Har ikke rekruttert ennå

Studietype

Observasjonsmessig

Registrering (Antatt)

120

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population consists of adult patients (aged 18 years and older) presenting with a first-ever acute ischemic stroke (AIS) who are admitted to the emergency department, neurology wards, or stroke unit within 48 hours of initial symptom onset. Diagnosis must be confirmed clinically and supported by objective neuroimaging findings via emergency CT or MRI scans. The population excludes patients with in-hospital stroke onset, transient ischemic attacks (TIAs), stroke mimics, severe pre-existing functional disability (defined as a baseline pre-stroke Modified Rankin Scale score > 2), and terminal co-morbidities with a life expectancy of less than 6 months.

Beskrivelse

Inclusion Criteria:

  • Patients aged >= 18 years at the time of presentation.
  • Confirmed clinical diagnosis of acute first-ever ischemic stroke supported by objective neuroimaging findings via history case taking and emergency CT or MRI scans.
  • Hospital admission initiated within 48 hours of initial symptom onset.
  • Informed consent provided, signed, and dated by the patient or a legally authorized proxy representative.

Exclusion Criteria:

  • In-hospital stroke onset.
  • Diagnosis of a Transient Ischemic Attack (TIA) or presenting stroke mimics (e.g., complex migraines, severe hypoglycemia, conversion disorders, status epilepticus).
  • Pre-existing severe functional disability prior to the index stroke event, established as a baseline pre-stroke Modified Rankin Scale (mRS) score > 2.
  • Co-morbid advanced or terminal medical or neurological or psychiatric conditions with a documented clinical life expectancy of less than 6 months.
  • Incomplete medical charts, structural data gaps, or formal withdrawal on baseline assessment or on hospital stay assessment before discharge.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
High Urgency Symptoms
Patients with a first-ever acute ischemic stroke (AIS) presenting with "high urgency" classic symptoms, such as sudden hemiplegia/hemiparesis, severe facial droop, or profound aphasia. These patients are admitted for acute stroke management and will receive specific stroke interventions (e.g., rTPA or mechanical thrombectomy) if they meet the eligibility criteria.
Low Urgency or Vague Symptoms
Patients with a first-ever acute ischemic stroke (AIS) presenting with "low urgency" or vague symptoms, which may include sensory deficits, vestibular symptoms, visual disturbances, new-onset headache, wake-up strokes, or altered mental status. These patients are admitted for conventional ward care, undergoing a standard medical workup and generalized nursing management.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Functional Dependence Assessed by the Modified Rankin Scale (mRS)
Tidsramme: 2 weeks after discharge
The degree of functional dependence and overall functional assessment of acute ischemic stroke patients will be estimated using the Modified Rankin Scale (mRS). Scores range from 0 to 6, where 0 represents no symptoms and 6 represents death, with higher scores indicating worse functional dependence.
2 weeks after discharge
Functional Dependence Assessed by the Modified Rankin Scale (mRS)
Tidsramme: 1 month after discharge
The degree of functional dependence and overall functional assessment of acute ischemic stroke patients will be estimated using the Modified Rankin Scale (mRS). Scores range from 0 to 6, where 0 represents no symptoms and 6 represents death, with higher scores indicating worse functional dependence.
1 month after discharge
Functional Dependence Assessed by the Modified Rankin Scale (mRS)
Tidsramme: 2 months after discharge
The degree of functional dependence and overall functional assessment of acute ischemic stroke patients will be estimated using the Modified Rankin Scale (mRS). Scores range from 0 to 6, where 0 represents no symptoms and 6 represents death, with higher scores indicating worse functional dependence.
2 months after discharge

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. oktober 2027

Datoer for studieregistrering

Først innsendt

1. august 2026

Først innsendt som oppfylte QC-kriteriene

5. august 2026

Først lagt ut (Faktiske)

6. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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