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

NCT07750847 | Not Yet Recruiting

• 1 other identifier: AIS Symptoms: Time & Outcomes
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Ischemic Stroke; Ischemic Stroke; Stroke

Keywords

Presenting Symptoms; Time Treatment Window; Clinical Outcome; Onset-to-Door Time; Reperfusion Therapy; High Urgency Symptoms; Door-to-Needle Time

Outcome Measures

Primary Outcomes (3)

• Functional Dependence Assessed by the Modified Rankin Scale (mRS)

  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)

  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)

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Neurology and Psychiatry

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08