- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03734796
Hs-cTnI Diagnosis of NSTE-ACS Patients in China (HEADLINES)
The Study of High-sEnsitivity cArDiac Troponin I vaLues and Changes In diagNosis of suspEcted Acute Coronary Syndrome Patients in China
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Cardiac Troponin is recommended as a preferred cardiac biomarker in third universal definition of myocardial infraction. The validated high-sensitive cardiac troponin I is also considered competent 1-hour algorithm to rule out and/ rule in NSTEMI in 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. However, the diagnostic threshold of 1-hour and 3-hour need more solid evidence in Chinese population. This study is to validate 1-hour and 3-hours diagnostic strategy using Architect high-sensitivity cardiac troponin I (hs-cTnI) in Chinese patients with suspected non-ST-elevation Myocardial Infarction (NSTEMI). The accuracy of 1-hour and 3-hours algorithm of NSTEMI using Architect hs-cTnI assays will be assessment in China emergency patients. This trail is going to determine the optimal diagnostic cut-off value of NSTEMI in Chinese population according to 24-hour or even longer clinical diagnosis of MI in routine way.
In primary phase of the present study, 400 patients with acute chest pain, who suspected NSTE-ACS, will be enrolled when visiting emergency department of Fuwai hospital. In subsequent study, multi center emergency department in China plan to recruit 2000 patients suspected NSTE-ACS. The inclusion and exclusion criteria had been described in the following eligibility part. All recruited patients undergo an initial clinical assessment including clinical history, physical examination, 12-lead ECG monitoring, routine blood measurements and echocardiogram. The blood samples of patients will be collected according to standard biobank protocol. Cardiac troponin I, CK-MB and myoglobin will be measured at presentation, 1-hour, 3-hours and 12-hours employing contemporary cTnI and high-sensitive cTnI, respectively.
The diagnosis of each enrolled patient will be made according to routine clinical approach and 1-hour and 3-hours clinical approach, respectively. The routine clinical diagnosis will be made by cardiologist panel according to third universal definition of myocardial infraction through reviewing all available medical records. The NSTEMI diagnosis depended on Architect hs-cTnI assessment will be made a senior cardiologist according to 1-hour and 3-hours clinical approach recommended by 2015 ESC guidelines for the management of NSTEMI. When there was disagreement about the diagnosis, cases were reviewed and adjudicated in conjunction with a third senior cardiologist.
Finally, statistical expert will evaluate the diagnostic performance of 1-hour and 3-hours clinical approach and diagnostic threshold of NSTEMI when the new hs-cTnI employed.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yan Liang, MD
- Número de teléfono: +861088322803
- Correo electrónico: fwliangyan2016@163.com
Copia de seguridad de contactos de estudio
- Nombre: Zhou Zhou, MD, PhD
- Número de teléfono: +861088398055
- Correo electrónico: fwcomd@126.com
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100037
- Reclutamiento
- Yan Liang
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Contacto:
- Yahui Lin, Ph.D.
- Número de teléfono: +8610-88398271
- Correo electrónico: linyahui@263.net
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 18-75y;
- highly suspected NSTEMI;
- ECG results without ST-segment elevation;
- without new Left bundle branch block (LBBB) ;
Exclusion Criteria:
- STEMI;
- underwent major surgical operation or injury within four weeks;
- medium and several kidney dysfunction (Ccr<30ml/min);
- anemia(Hb<90g/L);
- acute myocarditis;
- chronic cardiac dysfunction (NYHA III-IV);
- serious cardiac arrhythmias;
- Have had similar symptoms and treatment with thrombolysis before one month;
- history of intravenous drug;
- history of oncosis;
- pregnant;
- even recruited;
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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suspected NSTEMI
Patients aged 18-75 years old and highly suspected NSTEMI without Left bundle branch block (LBBB) will be included.
Patients will be excluded if who is STEMI, underwent surgical operation within four weeks, medium and several kidney dysfunction (Ccr<30ml/min), anemia, acute myocarditis, chronic cardiac dysfunction (NYHA III-IV), serious cardiac arrhythmias, with history of intravenous drug, oncosis and recent thrombolysis treatment, or pregnant.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Acute Myocardial Infarction
Periodo de tiempo: 0 - 72 hour
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Number of Participants with NSTEMI
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0 - 72 hour
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Yan Liang, MD, Department of Emergency Medicine, State Key Laboratory of Cardiovascular Disease National Center for Cardiovascular Diseases & Fuwai Hospital Peking Union Medical College & Chinese Academy of Medical Sciences
- Silla de estudio: Zhou Zhou, MD, PhD, Center of Laboratory Medicine Beijing Key Laboratory for Molecular Diagnostics of Cardiovascular Disease State Key Laboratory of Cardiovascular Disease National Center for Cardiovascular Diseases & Fuwai Hospital Peking Union Medical College & Chinese Aca
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HEADLINES
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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