Certainty Of Stroke Symptom Onset Study (COSSO)

January 14, 2019 updated by: Dong-Wha Kang, Asan Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients who cannot explain the symptom onset due to altered consciousness, aphasia, or cognitive decline

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)

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
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)
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
The factors will be obtained the day after admission (within 48 hours from symptom onset)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asan Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dong-Wha Kang, MD, Department of Neurology, Asan Medical Center

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COSSO

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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