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出境医 / 临床实验 / Characteristics, Treatment, and Economic Burden of Patients With CVD,CKD or at High Cardiovascular Risk

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

Study Description
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.

Condition or disease
Cardiovascular Abnormalities Chronic Kidney Diseases Diabetes

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);
Study Design
Layout table for study information
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
Arms and Interventions
Group/Cohort
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.
Outcome Measures
Primary Outcome Measures :
  1. The number of diabetic/non-diabetic patients with disease or risk [ Time Frame: 10 months after enrollment ]
    The number of diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk among all patients with diabetes;

  2. The proportion of diabetic/non-diabetic patients with disease or risk [ Time Frame: 10 months after enrollment ]
    The proportion of diabetic/non-diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk among patients without diabetes

  3. The demographic characteristics of the last visit for all patients of the studied population [ Time Frame: 10 months after enrollment ]
    1. age at admission;
    2. gender;
    3. ethnic;
    4. insurance payment;

  4. The diagnosis of patients [ Time Frame: 10 months after enrollment ]
    The number of patients with diagnosis at the last visit

  5. The proportion of death [ Time Frame: 10 months after enrollment ]
    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.

  6. Random blood glucose (mmol/L) [ Time Frame: 12 months after enrollment ]
    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.

  7. HbA1C (%) [ Time Frame: 12 months after enrollment ]
    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.

  8. Department of discharge for hospitalized patients [ Time Frame: 12 months after enrollment ]
    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.

  9. serum creatinine (μmol/L) [ Time Frame: 12 months after enrollment ]
    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.

  10. eGFR (mL/min/1.73m2) [ Time Frame: 12 months after enrollment ]
    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.

  11. Microalbuminuria (MALB) (mg/24h) [ Time Frame: 12 months after enrollment ]
    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. High density lipoprotein (HDL) (mmol/L) [ Time Frame: 12 months after enrollment ]
    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.

  13. Low density lipoprotein (LDL) (mmol/L) [ Time Frame: 12 months after enrollment ]
    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.

  14. Total cholesterol (TC) (mmol/L) [ Time Frame: 12 months after enrollment ]
    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.

  15. Triglyceride (TG) (mmol/L) [ Time Frame: 12 months after enrollment ]
    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.


Secondary Outcome Measures :
  1. The number of patients with different treatment pattern [ Time Frame: 10 months after enrollment ]
    1. number of patients with the treatment of antiplatelet drug,statin,vasodilators.
    2. number of patients with the treatment of different insulin and OHA prescription;
    3. number of patients with the treatment of anti-hypertensive drugs (CCB, ACEI/ARB, beta-blocker and diuretic)
    4. number of patients with the treatment of statin and fibrates;
    5. number of patients with the treatment of the dialysis, ACEI/ARB and the kindney transplantation.

    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


  2. The length of stay in the hospital [ Time Frame: 12 months after enrollment ]
    describe the length of stay in the hospital of the last hospitalization, the length stay in the hospital for inpatients from 2008 to 2018.

  3. The economic burden [ Time Frame: 12 months after enrollment ]
    hospitalization cost of the studied population for the last visit; total cost and hospitalization cost of the studied population from 2008 to 2018.

  4. Numbers of admissions [ Time Frame: 12 months after enrollment ]
    The total number of admissions for inpatients from 2008 to 2018

  5. The proportion of re-hospitalization [ Time Frame: 12 months after enrollment ]
    The last visiting and previous one within 30 days and 90 days


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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).
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Xin Sun, PhD +8618980606047 sunx79@hotmail.com

Locations
Layout table for location information
China, Tian Jin
Tian Jin Healthcare Big Data Co. Ltd Recruiting
Tian Jin, Tian Jin, China, 300000
Contact: Yi Cui, PhD         
Sponsors and Collaborators
West China Hospital
Investigators
Layout table for investigator information
Study Director: Xin Sun, PhD The West China Hospital of Sichuan university
Tracking Information
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
 (submitted: May 17, 2019)
  • The number of diabetic/non-diabetic patients with disease or risk [ Time Frame: 10 months after enrollment ]
    The number of diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk among all patients with diabetes;
  • The proportion of diabetic/non-diabetic patients with disease or risk [ Time Frame: 10 months after enrollment ]
    The proportion of diabetic/non-diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk among patients without diabetes
  • The demographic characteristics of the last visit for all patients of the studied population [ Time Frame: 10 months after enrollment ]
    1. age at admission;
    2. gender;
    3. ethnic;
    4. insurance payment;
  • The diagnosis of patients [ Time Frame: 10 months after enrollment ]
    The number of patients with diagnosis at the last visit
  • The proportion of death [ Time Frame: 10 months after enrollment ]
    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.
  • Random blood glucose (mmol/L) [ Time Frame: 12 months after enrollment ]
    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.
  • HbA1C (%) [ Time Frame: 12 months after enrollment ]
    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.
  • Department of discharge for hospitalized patients [ Time Frame: 12 months after enrollment ]
    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.
  • serum creatinine (μmol/L) [ Time Frame: 12 months after enrollment ]
    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.
  • eGFR (mL/min/1.73m2) [ Time Frame: 12 months after enrollment ]
    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.
  • Microalbuminuria (MALB) (mg/24h) [ Time Frame: 12 months after enrollment ]
    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.
  • High density lipoprotein (HDL) (mmol/L) [ Time Frame: 12 months after enrollment ]
    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.
  • Low density lipoprotein (LDL) (mmol/L) [ Time Frame: 12 months after enrollment ]
    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.
  • Total cholesterol (TC) (mmol/L) [ Time Frame: 12 months after enrollment ]
    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.
  • Triglyceride (TG) (mmol/L) [ Time Frame: 12 months after enrollment ]
    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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 17, 2019)
  • The number of patients with different treatment pattern [ Time Frame: 10 months after enrollment ]
    1. number of patients with the treatment of antiplatelet drug,statin,vasodilators.
    2. number of patients with the treatment of different insulin and OHA prescription;
    3. number of patients with the treatment of anti-hypertensive drugs (CCB, ACEI/ARB, beta-blocker and diuretic)
    4. number of patients with the treatment of statin and fibrates;
    5. number of patients with the treatment of the dialysis, ACEI/ARB and the kindney transplantation.
    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
  • The length of stay in the hospital [ Time Frame: 12 months after enrollment ]
    describe the length of stay in the hospital of the last hospitalization, the length stay in the hospital for inpatients from 2008 to 2018.
  • The economic burden [ Time Frame: 12 months after enrollment ]
    hospitalization cost of the studied population for the last visit; total cost and hospitalization cost of the studied population from 2008 to 2018.
  • Numbers of admissions [ Time Frame: 12 months after enrollment ]
    The total number of admissions for inpatients from 2008 to 2018
  • The proportion of re-hospitalization [ Time Frame: 12 months after enrollment ]
    The last visiting and previous one within 30 days and 90 days
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:

  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);
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
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
  • Cardiovascular Abnormalities
  • Chronic Kidney Diseases
  • Diabetes
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 17, 2019)
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:

  • 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).
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Xin Sun, PhD +8618980606047 sunx79@hotmail.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sun Xin, West China Hospital
Study Sponsor West China Hospital
Collaborators Not Provided
Investigators
Study Director: Xin Sun, PhD The West China Hospital of Sichuan university
PRS Account West China Hospital
Verification Date May 2021