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

NCT03958760 | Completed

• 1 other identifier: CREAT-DIABETES
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Abnormalities; Chronic Kidney Diseases; Diabetes

Outcome Measures

Primary Outcomes (15)

• The number of diabetic/non-diabetic patients with disease or risk

  The number of diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk among all patients with diabetes;

  10 months after enrollment

• The proportion of diabetic/non-diabetic patients with disease or risk

  The proportion of diabetic/non-diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk among patients without diabetes

  10 months after enrollment

• The demographic characteristics of the last visit for all patients of the studied population

  1. age at admission; 2. gender; 3. ethnic; 4. insurance payment;

  10 months after enrollment

• The diagnosis of patients

  The number of patients with diagnosis at the last visit

  10 months after enrollment

• The proportion of death

  The proportion of death at the last visit; the proportion of death at admission of the last visit for inpatients in 2008, 2013 and 2018.

  10 months after enrollment

• Random blood glucose (mmol/L)

  The most recent value of random blood glucose (mmol/L) within the previous year for outpatients; the value of random blood glucose (mmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.

  12 months after enrollment

• HbA1C (%)

  The most recent value of HbA1C (%) within the previous year for outpatients; the value of HbA1C (%) at admission of the last visit for inpatients in 2008, 2013, 2018.

  12 months after enrollment

• Department of discharge for hospitalized patients

  Department of discharge of the last visit for hospitalized patients; and summarize the number of patients of different department of discharge in 2008, 2013, 2018.

  12 months after enrollment

• serum creatinine (μmol/L)

  The most recent value of serum creatinine (μmol/L) within the previous year for outpatients; the value of serum creatinine (μmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.

  12 months after enrollment

• eGFR (mL/min/1.73m2)

  The most recent value of eGFR (mL/min/1.73m2) within the previous year for outpatients; the value of eGFR (mL/min/1.73m2) at admission of the last visit for inpatients in 2008, 2013, 2018.

  12 months after enrollment

• Microalbuminuria (MALB) (mg/24h)

  The most recent value of microalbuminuria (MALB, mg/24h) within the previous year for outpatients; the value of microalbuminuria (MALB, mg/24h) at admission of the last visit for inpatients in 2008, 2013, 2018.

  12 months after enrollment

• High density lipoprotein (HDL) (mmol/L)

  The lasted examination of high density lipoprotein (HDL) (mmol/L) within the last year for outpatients; the value of high density lipoprotein (HDL) (mmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.

  12 months after enrollment

• Low density lipoprotein (LDL) (mmol/L)

  The lasted examination of low density lipoprotein (HDL) (mmol/L) within the last year for outpatients; the value of low density lipoprotein (HDL) (mmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.

  12 months after enrollment

• Total cholesterol (TC) (mmol/L)

  The lasted examination of total cholesterol (TC) (mmol/L) within the last year for outpatients; the value of total cholesterol (TC) (mmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.

  12 months after enrollment

• Triglyceride (TG) (mmol/L)

  The lasted examination of triglyceride (TG) (mmol/L) within the last year for outpatients; the value of triglyceride (TG) (mmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.

  12 months after enrollment

Secondary Outcomes (5)

• The number of patients with different treatment pattern

  10 months after enrollment

• The length of stay in the hospital

  12 months after enrollment

• The economic burden

  12 months after enrollment

• Numbers of admissions

  12 months after enrollment

• The proportion of re-hospitalization

  12 months after enrollment

Study Arms (4)

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.

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.

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.

Health controls

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Tian Jin Healthcare Big Data Co. Ltd

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Cardiovascular Abnormalities; Renal Insufficiency, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xin Sun, PhD

  The West China Hospital of Sichuan university

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 22, 2019
• Study Start: February 28, 2021
• Primary Completion: October 28, 2021
• Study Completion: December 28, 2021
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)