- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07750847
Impact of Presenting Symptoms on Treatment Time and Outcomes in Acute Ischemic Stroke
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
Studietype
Registrering (Antatt)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Dependence Assessed by the Modified Rankin Scale (mRS)
Tidsramme: 2 weeks after discharge
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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.
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2 weeks after discharge
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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
|
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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
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AIS Symptoms: Time & Outcomes
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