- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04903496
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
Characteristics, Treatment, and Economic Burden of Disease of Chinese Diabetic/Non-diabetic Patients With/Without Established Cardiovascular Disease, Chronic Kidney Disease, or at High Cardiovascular Risk
The study aims to investigate the clinical characteristics, treatment, and economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease (CVD), chronic kidney disease (CKD), or at high cardiovascular risk, including:
- Primary objectives: describe the proportion of Chinese diabetic/non-diabetic patients with established cardiovascular disease, CKD, or at high cardiovascular risk including hypertension and hyperlipidemia
- Secondary objectives: describe the demographic characteristics of the last visit for all patients, and the demographic characteristics of inpatients over time; investigate the clinical characteristic for all patients
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Chengdu, Porcelana, 610041
- Chengdu Big Data Association
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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:
- Patients in the Tianjin regional database from 01/01/2015 to 31/12/2019
- Group A: patients with diagnosis of diabetes, and with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk
- Group B: patients with diagnosis of diabetes, but not with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk
- Group C: patients with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, but not with diagnosis of diabetes
- Group D: patients without diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, and without diagnosis of diabetes. We will randomly select a group of non-diabetic patients without any of the above diseases by matching on age and gender
Definition of diabetes, cardiovascular disease, chronic kidney disease and high cardiovascular risk:
- Diabetes: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of diabetes (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (International classification of disease (ICD)-10 E10-E14);
- Cardiovascular disease: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of ischemic heart diseases (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I20~I25); or patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of cerebrovascular diseases (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I60~I69); or patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of ischemic peripheral artery disease (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 E10.501, E11.603, E14.501, E14.606, E14.503, I73.9, I99.03, I99.04);
- Heart failure: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of heart failure (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I50);
- Chronic kidney disease (CKD): inpatients with at least once 1 discharged diagnosis CKD (ICD-10 N18), or inpatients with the last estimated glomerular filtration rate (eGFR, calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation) <60 mL/min/1.73 m2 or prescription of dialysis, but not with the diagnosis of acute kidney injury (ICD-10 N17); or outpatients with at least 2 diagnosis of CKD (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) or with two consecutive eGFR (calculated by CKD-EPI equation) <60 mL/min/1.73 m2 by 90 days or more;
- High cardiovascular risk: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of hypertension (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I10~I15); or at least 1 discharged diagnosis or 2 outpatient diagnosis of hyperlipidemia (ICD-10 E78.001-E78.003, E78.101, E78.203, E78.301-E78.304, E78.306, E78.401, E78.501, E78.902);
Exclusion Criteria:
- Patients with non-Chinese nationalities
- Duplicated storage (records with same inpatient code)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Group A: Diabetic patients with CVD, CKD or at risk
The group A includes all Patients with diagnosis of diabetes, and with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk.
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Group B: Diabetic patients without CVD, CKD or at risk
The group B includes all patients with diagnosis of diabetes, but not with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk.
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Group C: Non-diabetic patients with CVD, CKD or at risk
The group C includes all patients with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, but not with diagnosis of diabetes.
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Group D: Non-diabetic patients without CVD, CKD or at risk
The group D includes all patients without diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, and without diagnosis of diabetes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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The proportion of diabetic/non-diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk
Periodo de tiempo: up to 4 years
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up to 4 years
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The proportion of diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk among all diabetic patients
Periodo de tiempo: up to 4 years
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up to 4 years
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The proportion of non-diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk among all non-diabetic patients
Periodo de tiempo: up to 4 years
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up to 4 years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Age at admission at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
Periodo de tiempo: up to 4 years
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up to 4 years
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Gender at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
Periodo de tiempo: up to 4 years
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up to 4 years
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Insurance payment at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
Periodo de tiempo: up to 4 years
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up to 4 years
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Discharge department at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)
Periodo de tiempo: up to 4 years
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up to 4 years
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Proportion of death at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)
Periodo de tiempo: up to 4 years
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up to 4 years
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The value of glycated hemoglobin (HbA1c) at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)
Periodo de tiempo: up to 4 years
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up to 4 years
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Concentration (nmol/L) of random blood glucose at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)
Periodo de tiempo: up to 4 years
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up to 4 years
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Serum creatine concentration (μmol/L) at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
Periodo de tiempo: up to 4 years
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up to 4 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 1245-0203
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Información sobre medicamentos y dispositivos, documentos del estudio
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