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Certainty Of Stroke Symptom Onset Study (COSSO)

2019년 1월 14일 업데이트: 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.

연구 개요

상태

빼는

상세 설명

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.

연구 유형

관찰

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

Ischemic stroke patients admitted to Acute Stroke Unit at Asan Medical Center Patients older than 20 years old Symptom onset within 24 hours

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Discrepancy (difference) in the time onset of stroke symptoms diagnosed by two different neurologists
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Factors influencing the subjective uncertainty of stroke symptom onset by patients
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Dong-Wha Kang, MD, Department of Neurology, Asan Medical Center

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 8월 1일

기본 완료 (예상)

2014년 6월 1일

연구 완료 (예상)

2014년 8월 1일

연구 등록 날짜

최초 제출

2013년 8월 11일

QC 기준을 충족하는 최초 제출

2013년 8월 26일

처음 게시됨 (추정)

2013년 8월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 1월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 1월 14일

마지막으로 확인됨

2019년 1월 1일

추가 정보

이 연구와 관련된 용어

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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