- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Chengdu, 중국, 610041
- Chengdu Big Data Association
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The proportion of diabetic/non-diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk
기간: 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
기간: 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
기간: up to 4 years
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up to 4 years
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2차 결과 측정
결과 측정 |
기간 |
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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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: up to 4 years
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up to 4 years
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- 1245-0203
개별 참가자 데이터(IPD) 계획
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