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

August 5, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Dependence Assessed by the Modified Rankin Scale (mRS)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

August 1, 2026

First Submitted That Met QC Criteria

August 5, 2026

First Posted (Actual)

August 6, 2026

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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