Characteristics, Treatment, and Economic Burden of Patients With CVD,CKD or at High Cardiovascular Risk

NCT ID: NCT03958760

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2021-12-28

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:

1. estimate the proportion of Chinese diabetic/non-diabetic patients with established cardiovascular disease, CKD, or at high cardiovascular risk including hypertension and hyperlipidaemia;

2. describe the demographic and clinical characteristics of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;

3. investigate the treatment patterns of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;

4. examine economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;

5. explore the trends of clinical characteristics, treatment pattern, economic burden of inpatients over time (2008, 2013, and 2018 separately);

Conditions

Cardiovascular Abnormalities; Chronic Kidney Diseases; Diabetes

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Health controls

The group D included non-diabetic patients without established cardiovascular disease, chronic kidney disease, and not at high cardiovascular risk.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients in the TianJin regional database from 2015 to 2018.
• patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of ischemic heart diseases (ICD-10 I20~I25);
• patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of cerebrovascular diseases (ICD-10 I60~I69);
• patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of ischemic peripheral artery disease (ICD-10 E10.501, E11.603, E14.501, E14.606, E14.503, I73.9, I99.03, I99.04);
• patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of heart failure (ICD-10 I50);
• inpatients with at least once 1 discharged diagnosis CKD (ICD-10 N18), or inpatients with the last estimated glomerular filtration rate (eGFR, calculated by 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)
• Outpatients with at least 2 diagnosis of CKD or with two consecutive eGFR(calculated by CKD-EPI equation) <60 mL/min/1.73 m2 by 90 days or more.
• patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of hypertension (ICD-10 I10~I15);
• at least 1 discharged diagnosis or 2 outpatient diagnosis of hyperlipidaemia (ICD-10 E78.001-E78.003, E78.101, E78.203, E78.301-E78.304, E78.306, E78.401, E78.501, E78.902)
• patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of diabetes (ICD-10 E10-E14)
• In addition, we will randomly select a group of non-diabetic patients without any of the above diseases by matching on age and gender.

Exclusion Criteria

• Patients with non-Chinese nationalities;
• Patients with abnormal bill (planning to define abnormal bill as the top 1-2.5% of total medical costs in three groups, respectively, but the final standard will be defined based on the real extracted data);
• Duplicated storage (records with same inpatient code).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sun Xin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Sun, PhD

Role: STUDY_DIRECTOR

The West China Hospital of Sichuan university

Locations

Tian Jin Healthcare Big Data Co. Ltd

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

CREAT-DIABETES

Identifier Type: -

Identifier Source: org_study_id