Ischemic StrokeCOSSONCT01928641
Certainty Of Stroke Symptom Onset Study
An observational study of Ischemic Stroke, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Intravenous tissue plasminogen activator (IV t-PA) is the only proven treatment of hyperacute cerebral infarction. The outcome of this treatment highly depends on the time from symptom onset to the administration of thrombolytic agent. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic stroke patients admitted to Acute Stroke Unit at Asan Medical Center Patients older than 20 years old Symptom onset within 24 hours
Who may be able to join
- ischemic stroke patients admitted to Acute Stroke Unit at Asan Medical Center
- ischemic stroke patients older than 20 years old
- symptom onset within 24 hours
Who cannot join
- patients who cannot explain the symptom onset due to altered consciousness, aphasia, or cognitive decline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Certainty of Stroke Symptom Onset
Intravenous tissue plasminogen activator (IV t-PA) is the only proven treatment of hyperacute cerebral infarction. The outcome of this treatment highly depends on the time from symptom onset to the administration of thrombolytic agent. Last known normal time is widely used as the standard to determine the symptom onset. These stroke symptoms are usually caused by a sudden decrease in cerebral blood flow related with an embolic or thrombotic event. However, in some cases various symptoms may occur one after another.
Myocardial infarction is also caused by a sudden caseation of blood flow. The symptom of myocardial infarction usually contains chest pain, and it is easy to identify the exact time of onset. In contrast, cerebral infarction may cause various symptoms according to the infarcted area of the brain, and sometimes multiple symptoms are presented in rapid succession. Therefore, it may be much unclear and uncertain to determine the onset time of cerebral infarction. Despite the importance of onset time in therapeutic decision making, there was no study focusing on the certainty of onset time in cerebral infarction patients.
In this study, we will investigate the subjective certainty of patient about the onset time in clear-onset cerebral ischemia. The discrepancy in diagnosing the onset time will be analyzed among the clinicians involved in the practice. Then, the factors associated with this uncertainty will be verified.
Read the detailed description
On the day after admission, the patients will be re-interviewed by a stroke neurologist during the rounding in the morning. First the history of symptom onset will be re-taken once more, focusing on the presentation of each neurological symptom. Then the history taken from the emergency department including the onset time will be presented to the patient, and the patient will be asked to choose the certainty for the onset time between 1 and 5.
The symptom onset judged by the neurologist first assessed at the emergency department will be compared to that of the stroke neurologist re-interviewed after admission. If any discrepancy exists, the history of the patient will be re-written by the stroke neurologist and then reviewed by five experienced stroke neurologist. The judgment on stroke onset and the certainty of each stroke neurologist will be compared.
Clinical variables will be obtained from the patient. The informant will be the patient. Demographics including the age and sex will be obtained. Additionally the year of education will be investigated. The situation of stroke onset will be obtained in detail. What the patient was doing immediately before the onset, the place, and the person accompanied with will also be investigated. These will be described on the re-written history which will be reviewed by the five stroke neurologists. The conventional risk factors for stroke and the stroke etiology according to the TOAST classification will be acquired. The initial severity of stroke will also be obtained evaluated by National Institutes of Health Stroke Scale (NIHSS). On the second interview and the re-written history, the symptoms will be investigated in detail. First as an open question, and then targeting the stroke symptoms and the onset of them will be asked. The symptom includes 1) weakness, 2) facial palsy 3) dysarthria 4) ataxia 5) visual field defect 6) sensory change 7) dizziness 8) headache and 9) Other non-specific symptoms. The onset time and the sequence will be investigated by each symptom.
The result will be analyzed in two view points. First the discrepancy rate between clinicians will be first examined, and the clinical variables making difference will be analyzed. finally a protocol for systemized history taking of stroke onset will be used, and the change will be analyzed before and after the release of protocol.
In the second point of veiw, the certainty of patient will be analyzed. The clinical variables will be compared according to the certainty of patient on symptom onset.
- Conditions
- Ischemic Stroke
- Medical subject headings
- Ischemic 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 |
|---|---|---|
| Discrepancy in stroke onset | Patients with discrepancy in stroke symptom onset based on the diagnosis of the first neurologist who evaluated the patient at emergency room and the next day after admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrepancy (difference) in the time onset of stroke symptoms diagnosed by two different neurologists
The onset time assessed at emergency departement by a neurologist will be compared to the onset time assessed next day after admission by a different neurologist.
Measured: Onset time will be obtained two times,first at the visit time of emergency department (within 24 hours from onset) and secondly the day after admission (within 48 hours from onset)
Secondary outcomes (2)
Factors influencing the subjective uncertainty of stroke symptom onset by patients
The subjective uncertainty of the stroke symptom onset will be analyzed based on numerical scale from 1 to 5.
Factors influencing the uncertainty will be investigated. Demographic factors, risk factors, stroke subtype, symptoms of stroke will be compared between patients with different certainty to stroke symptom onset
Measured: The subjective certainty will be obtained the day after admission (within 48 hours from onset)
Factor influencing the objective discrepancy of stroke symptom onset diagnosed by two different neurologists
Demographic factors, risk factors, stroke subtype, symptoms of stroke will be compared between patients with and without discrepancy on symptom onset of stroke diagnosed by two different neurologists
Measured: The factors will be obtained the day after admission (within 48 hours from symptom onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014 (estimated)
- Study completionAug 2014 (estimated)
Why it stopped: Main investigator changed affiliation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Wha Kang, Asan Medical Center
- Investigators
- Dong-Wha Kang, MD, Principal investigator, Department of Neurology, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928641
- Sponsor's protocol ID
- COSSO
- Acronym
- COSSO
- Status last verified
- Jan 2019
- First submitted
- 11 Aug 2013
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Certainty of Stroke Symptom Onset
- ClinicalTrials.gov ID
- NCT01928641
- Acronym / sponsor ID
- COSSO / COSSO
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Main investigator changed affiliation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 27 Aug 2013 (estimated)
- 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.
Intravenous tissue plasminogen activator (IV t-PA) is the only proven treatment of hyperacute cerebral infarction. The outcome of this treatment highly depends on the time from symptom onset to the administration of thrombolytic agent. Last known normal time is widely used as the standard to determine the symptom onset. These stroke symptoms are usually caused by a sudden decrease in cerebral blood flow related with an embolic or thrombotic event. However, in some cases various symptoms may occur one after another.
Myocardial infarction is also caused by a sudden caseation of blood flow. The symptom of myocardial infarction usually contains chest pain, and it is easy to identify the exact time of onset. In contrast, cerebral infarction may cause various symptoms according to the infarcted area of the brain, and sometimes multiple symptoms are presented in rapid succession. Therefore, it may be much unclear and uncertain to determine the onset time of cerebral infarction. Despite the importance of onset time in therapeutic decision making, there was no study focusing on the certainty of onset time in cerebral infarction patients.
In this study, we will investigate the subjective certainty of patient about the onset time in clear-onset cerebral ischemia. The discrepancy in diagnosing the onset time will be analyzed among the clinicians involved in the practice. Then, the factors associated with this uncertainty will be verified.
Detailed description
On the day after admission, the patients will be re-interviewed by a stroke neurologist during the rounding in the morning. First the history of symptom onset will be re-taken once more, focusing on the presentation of each neurological symptom. Then the history taken from the emergency department including the onset time will be presented to the patient, and the patient will be asked to choose the certainty for the onset time between 1 and 5.
The symptom onset judged by the neurologist first assessed at the emergency department will be compared to that of the stroke neurologist re-interviewed after admission. If any discrepancy exists, the history of the patient will be re-written by the stroke neurologist and then reviewed by five experienced stroke neurologist. The judgment on stroke onset and the certainty of each stroke neurologist will be compared.
Clinical variables will be obtained from the patient. The informant will be the patient. Demographics including the age and sex will be obtained. Additionally the year of education will be investigated. The situation of stroke onset will be obtained in detail. What the patient was doing immediately before the onset, the place, and the person accompanied with will also be investigated. These will be described on the re-written history which will be reviewed by the five stroke neurologists. The conventional risk factors for stroke and the stroke etiology according to the TOAST classification will be acquired. The initial severity of stroke will also be obtained evaluated by National Institutes of Health Stroke Scale (NIHSS). On the second interview and the re-written history, the symptoms will be investigated in detail. First as an open question, and then targeting the stroke symptoms and the onset of them will be asked. The symptom includes 1) weakness, 2) facial palsy 3) dysarthria 4) ataxia 5) visual field defect 6) sensory change 7) dizziness 8) headache and 9) Other non-specific symptoms. The onset time and the sequence will be investigated by each symptom.
The result will be analyzed in two view points. First the discrepancy rate between clinicians will be first examined, and the clinical variables making difference will be analyzed. finally a protocol for systemized history taking of stroke onset will be used, and the change will be analyzed before and after the release of protocol.
In the second point of veiw, the certainty of patient will be analyzed. The clinical variables will be compared according to the certainty of patient on symptom onset.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Discrepancy in stroke onset | – | –Patients with discrepancy in stroke symptom onset based on the diagnosis of the first neurologist who evaluated the patient at emergency room and the next day after admission |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic stroke patients admitted to Acute Stroke Unit at Asan Medical Center Patients older than 20 years old Symptom onset within 24 hours
Key inclusion criteria (3 listed)
- ischemic stroke patients admitted to Acute Stroke Unit at Asan Medical Center
- ischemic stroke patients older than 20 years old
- symptom onset within 24 hours
Key exclusion criteria (1 listed)
- patients who cannot explain the symptom onset due to altered consciousness, aphasia, or cognitive decline
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
Discrepancy (difference) in the time onset of stroke symptoms diagnosed by two different neurologists
Time frame: Onset time will be obtained two times,first at the visit time of emergency department (within 24 hours from onset) and secondly the day after admission (within 48 hours from onset)
The onset time assessed at emergency departement by a neurologist will be compared to the onset time assessed next day after admission by a different neurologist.
2 secondary outcomes
Factors influencing the subjective uncertainty of stroke symptom onset by patients
Time frame: The subjective certainty will be obtained the day after admission (within 48 hours from onset)
Factor influencing the objective discrepancy of stroke symptom onset diagnosed by two different neurologists
Time frame: The factors will be obtained the day after admission (within 48 hours from symptom onset)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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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. This study is not recruiting at the moment.
Dong-Wha Kang, MD principal investigator
Department of Neurology, Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Asan Medical Center at 1 site in South Korea.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Discrepancy (difference) in the time onset of stroke symptoms diagnosed by two different neurologists (time frame: Onset time will be obtained two times,first at the visit time of emergency department (within 24 hours from onset) and secondly the day after admission (within 48 hours from onset)). 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 16 Jan 2019; AzTrials last refreshed its copy on 4 Nov 2026.