Condition or disease |
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Cardiovascular Abnormalities Chronic Kidney Diseases Diabetes |
The study aimed to investigate the clinical 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, including:
Study Type : | Observational |
Estimated Enrollment : | 200000 participants |
Observational Model: | Other |
Time Perspective: | Retrospective |
Official Title: | 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 |
Actual Study Start Date : | February 28, 2021 |
Estimated Primary Completion Date : | October 28, 2021 |
Estimated Study Completion Date : | December 28, 2021 |
Group/Cohort |
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Diabetic patients with CVD, CKD or at risk
The group A include all diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk.
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Diabetic patients without CVD, CKD or at risk
The group B include all diabetic patients without established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk.
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Non-diabetic patients with CVD, CKD or at risk
The group C included all non-diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk.
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Health controls
The group D included non-diabetic patients without established cardiovascular disease, chronic kidney disease, and not at high cardiovascular risk.
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We descirbe the treatment pattern based on treatment prescribed during the most recent visit for all inpatients, and based on at least 2 prescription within the previous year for outpatients
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Xin Sun, PhD | +8618980606047 | sunx79@hotmail.com |
China, Tian Jin | |
Tian Jin Healthcare Big Data Co. Ltd | Recruiting |
Tian Jin, Tian Jin, China, 300000 | |
Contact: Yi Cui, PhD |
Study Director: | Xin Sun, PhD | The West China Hospital of Sichuan university |
Tracking Information | |||||
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First Submitted Date | April 22, 2019 | ||||
First Posted Date | May 22, 2019 | ||||
Last Update Posted Date | May 28, 2021 | ||||
Actual Study Start Date | February 28, 2021 | ||||
Estimated Primary Completion Date | October 28, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Characteristics, Treatment, and Economic Burden of Patients With CVD,CKD or at High Cardiovascular Risk | ||||
Official Title | 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 | ||||
Brief Summary | The heavy disease burden is mainly due to diabetic complications. Diabetes is a major risk factor for cardiovascular disease (CVD) and chronic kidney disease (CKD).China has been the largest absolute disease burden of diabetes in the world recently1. Diabetic patients with established CVD or CKD are bringing growing pressure upon our nation's healthcare expenditure1. However, the characteristic profile of Chinese diabetic patients who has CVD, CKD or at high risk of CVD remains unclear thus is in urgent need for in-depth investigation.In current China, however, the information regarding diabetes or non-diabetes patients who also had other comorbid conditions (e.g. established CV diseases, CKD or at high risk for such problem), is limited; the patient characteristics, treatment patterns and economic burden may not be fully understood.Therefore, based on TianJin regional database, the investigators will describe the demographic, clinical characteristics, treatment, and economic burden of disease of Chinese diabetic/non-diabetic patients with/without established CV disease, CKD, or at high CV risk including hypertension and hyperlipidaemia. And the investigators believe that the resulting findings will inform a comprehensive group of evidence users to achieve better healthcare for diabetes patients with established or at high risk of CVD or CKD. | ||||
Detailed Description |
The study aimed to investigate the clinical 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, including:
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Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Diabetic/non-diabetic patients with/without established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk in TianJin regional database | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
200000 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 28, 2021 | ||||
Estimated Primary Completion Date | October 28, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03958760 | ||||
Other Study ID Numbers | CREAT-DIABETES | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Sun Xin, West China Hospital | ||||
Study Sponsor | West China Hospital | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | West China Hospital | ||||
Verification Date | May 2021 |