Acute Ischemic StrokeNCT07750847
Impact of Presenting Symptoms on Treatment Time and Outcomes in Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke and Ischemic Stroke, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Ischemic Stroke, Stroke
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Ramadan Abdelazeem Saleh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750847
- Sponsor's protocol ID
- AIS Symptoms: Time & Outcomes
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Presenting Symptoms in Ischemic Stroke Onset on Time Treatment Window and Clinical Outcome of Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT07750847
- Acronym / sponsor ID
- AIS Symptoms: Time & Outcomes
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Ischemic Stroke, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Dependence Assessed by the Modified Rankin Scale (mRS) (time frame: 2 weeks after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.