Certainty Of Stroke Symptom Onset Study

NCT01928641 | Withdrawn DMC

• 1 other identifier: COSSO
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  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 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

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

Study Arms (1)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Dong-Wha Kang

Seoul, 138-372, South Korea

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Dong-Wha Kang, MD

  Department of Neurology, Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2013
• First Posted: August 27, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

KR (1)