- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07601659
Prospective Italian Validation of SMS in Patients With Suspected Acute Stroke (PIVA-SMS)
Prospective Italian Multicenter Study for the Validation of the Stroke Mimics Score (SMS) in Patients With Suspected Acute Stroke
The overall objective of the study is to prospectively validate the diagnostic accuracy of the Stroke Mimics Score (SMS). This score is calculated using information collected at the time of the patient's arrival in the Emergency Department (triage) and may assist clinicians in distinguishing between:
- cerebrovascular events (ischemic stroke, intracerebral hemorrhage, and transient ischemic attack [TIA]),
- stroke mimics (i.e., conditions that present with stroke-like symptoms but without actual infarction of brain tissue).
In addition, the study aims to compare its results with other existing tools and to evaluate its performance across different patient groups.
Specifically, the present research seeks to generate data on the reliability of the SMS tool in providing an accurate diagnosis.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Giovanni Frisullo
- 전화번호: +393476612284
- 이메일: giovanni.frisullo@policlinicogemelli.it
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
Adult patients presenting to the Emergency Department with suspected acute stroke during the enrollment period.
The final discharge diagnosis will serve as the gold standard.
설명
Inclusion Criteria:
- Age ≥ 18 years at the time of presentation to the Emergency Department.
- Presentation to the Emergency Department with a clinical suspicion of acute stroke, identified at nursing triage and/or through activation of the stroke pathway.
- Presentation to the Emergency Department during the 6-month prospective enrollment period.
- Feasibility of real-time collection of the data required to calculate the Stroke Mimics Score (SMS), including:
age, systolic blood pressure, presence/absence of seizure at onset, presence/absence of headache at onset, presence/absence of confusion at onset, presence/absence of syncope at onset, presence/absence of isolated sensory deficit, presence/absence of motor deficit, history of coronary artery disease, history of prior stroke or transient ischemic attack (TIA).
- Availability of a final hospital discharge diagnosis at the end of hospitalization or Emergency Department observation.
- Signed informed consent from the patient or caregiver. If the patient is unconscious upon arrival at the Emergency Department, deferred consent will be applied.
Exclusion Criteria:
- Age < 18 years.
- Inability to fully collect the data required to calculate the Stroke Mimics Score (SMS).
- Absence of a clearly defined final hospital discharge diagnosis.
- Voluntary discharge, transfer, or death before completion of the diagnostic workup, in the absence of a reliable diagnosis.
- Repeated Emergency Department visits for the same clinical event (only the first visit will be considered).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The rate of accuracy of Stroke Mimics Score (SMS)
기간: through study completion, about 1 year
|
Diagnostic accuracy of the Stroke Mimics Score (SMS) in discriminating between:
assessed by: Area Under the Receiver Operating Characteristic Curve (AUROC). The AUROC will be calculated with a 95% confidence interval. An AUROC value significantly higher than 0.70 will be considered indicative of an acceptable discriminative ability of the score. |
through study completion, about 1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Analyses across clinical subgroups
기간: through study completion, about 1 year
|
To evaluate sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), score calibration, the performance of the grouped version (SMSg), comparison with FABS and TMS, and analyses across clinical subgroups.
|
through study completion, about 1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Giovanni Frisullo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .