Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery
Cardiovascular disease (CVD) is the leading cause of global morbidity and mortality, with its prevalence increasing significantly from 1990 to 2019. Establishing a comprehensive cardiac surgery database is crucial for exploring perioperative prognostic factors and improving clinical outcomes.
This muti-center, prospective observational study aims to construct a prospective cohort database for perioperative cardiac surgery. We plan to enroll adult patients who undergo cardiac surgery with cardiopulmonary bypass at the Second Affiliated Hospital of Zhejiang University and other hospitals from May 1, 2026 to December 31, 2031. Multi-dimensional perioperative data, including laboratory tests, hemodynamics, intraoperative echocardiography, and perioperative medications, will be collected and integrated, along with epidemiological data, clinical diagnosis and treatment information, multimodal data, and follow-up outcomes. An interconnected big data sharing platform will also be built.
This database will provide a valuable resource for multi-level researches such as perioperative risk assessment, individualized prevention, precise diagnosis and treatment, and therapeutic efficacy monitoring. It will also help optimize surgical and perioperative management, improve the quality of cardiac surgery, and provide evidence for the refinement of China's healthcare system, ultimately enhancing perioperative safety and rehabilitation efficiency of patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Min Yan, Doctor
- Número de teléfono: 15888210247
- Correo electrónico: zryanmin@zju.edu.cn
Ubicaciones de estudio
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Zhejiang
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Hangzhou, Zhejiang, Porcelana
- Reclutamiento
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031
Exclusion Criteria:
- Refusal to provide informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Perioperative Observation Group
Patients undergoing cardiac surgery with cardiopulmonary bypass during the perioperative period (including, but not limited to, valve surgery, coronary artery bypass grafting, and combined procedures that require cardiopulmonary bypass)
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Cardiac surgey
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Periodo de tiempo: 4, 12 weeks and 1years after surgery
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Myocardial infarction; New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion; Death
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4, 12 weeks and 1years after surgery
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Incidence of Perioperative Transfusion of Allogeneic Blood Products
Periodo de tiempo: 30 days after surgery
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Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
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30 days after surgery
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Amount of Allogeneic Blood Products Transfused During the Perioperative Period
Periodo de tiempo: 30 days after surgery
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Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
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30 days after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidencia de readmisión hospitalaria no planificada dentro de las 4 y 12 semanas posteriores a la cirugía
Periodo de tiempo: 4 y 12 semanas después de la cirugía
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Reingreso hospitalario no planificado
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4 y 12 semanas después de la cirugía
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Incidence of perioperative myocardial infarction
Periodo de tiempo: 4, 12 weeks and 1years after surgery
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Myocardial infarction
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4, 12 weeks and 1years after surgery
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Incidence of New-onset stroke
Periodo de tiempo: 4, 12 weeks and 1years after surgery
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New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion
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4, 12 weeks and 1years after surgery
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Incidence of death
Periodo de tiempo: 4, 12 weeks and 1years after surgery
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death
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4, 12 weeks and 1years after surgery
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Incidence of acute kidney injury
Periodo de tiempo: 7days after suegery
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acute kidney injury was defined by guidelines of kindey disease：improving global outcomes（KIDGO）
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7days after suegery
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Incidence of infectious complications
Periodo de tiempo: 4, 12 weeks and 1years after surgery
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Infectious complications include, but are not limited to, pneumonia, surgical site infection, etc.
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4, 12 weeks and 1years after surgery
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Length of hospital stay
Periodo de tiempo: Through patients discharge, an average of 7 days after surgery
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Length of hospital stay
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Through patients discharge, an average of 7 days after surgery
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Hospitalization costs
Periodo de tiempo: Through patients discharge, an average of 7 days after surgery
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Hospitalization costs
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Through patients discharge, an average of 7 days after surgery
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Quality of life scores
Periodo de tiempo: at 4, 12 weeks and 1 years after surgery
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Quality of life was assessed using the EuroQol Five-Dimensional Questionnaire (EQ-5D) EuroQol Five-Dimensional Questionnaire (EQ-5D): The EQ-5D includes a visual analog scale (EQ-VAS) ranging from 0 to 100, where higher scores indicate better health status. |
at 4, 12 weeks and 1 years after surgery
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Quality of life scores
Periodo de tiempo: at 4, 12 weeks and 1 years after surgery
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Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Kansas City Cardiomyopathy Questionnaire (KCCQ): The KCCQ consists of 23 items that quantify the following domains: physical limitations, symptoms (including symptom frequency, severity, and change over time), self-efficacy, social function, and quality of life. The total score ranges from 0 to 100, with higher scores representing better quality of life. |
at 4, 12 weeks and 1 years after surgery
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-0345
Información sobre medicamentos y dispositivos, documentos del estudio
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