Cardiovascular AbnormalitiesNCT03958760
Characteristics, Treatment, and Economic Burden of Patients With CVD,CKD or at High Cardiovascular Risk
An observational study of Cardiovascular Abnormalities and Chronic Kidney Diseases, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Abnormalities, Chronic Kidney Diseases, Diabetes
- How many people
- 200,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2021to 28 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diabetic/non-diabetic patients with/without established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk in TianJin regional database
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Tian Jin Healthcare Big Data Co. Ltd
Tianjin, Tianjin Municipality, 300000
About this study
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
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.
Read the 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:
- estimate the proportion of Chinese diabetic/non-diabetic patients with established cardiovascular disease, CKD, or at high cardiovascular risk including hypertension and hyperlipidaemia;
- describe the demographic and clinical characteristics of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;
- investigate the treatment patterns of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;
- examine economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;
- explore the trends of clinical characteristics, treatment pattern, economic burden of inpatients over time (2008, 2013, and 2018 separately);
- Medical subject headings
- Cardiovascular Abnormalities, Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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
Measured: 10 months after enrollment
The demographic characteristics of the last visit for all patients of the studied population
- age at admission;
- gender;
- ethnic;
- insurance payment;
Measured: 10 months after enrollment
The diagnosis of patients
The number of patients with diagnosis at the last visit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after enrollment
Secondary outcomes (5)
The number of patients with different treatment pattern
- number of patients with the treatment of antiplatelet drug,statin,vasodilators.
- number of patients with the treatment of different insulin and OHA prescription;
- number of patients with the treatment of anti-hypertensive drugs (CCB, ACEI/ARB, beta-blocker and diuretic)
- number of patients with the treatment of statin and fibrates;
- 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
Measured: 10 months after enrollment
The length of stay in the hospital
describe the length of stay in the hospital of the last hospitalization, the length stay in the hospital for inpatients from 2008 to 2018.
Measured: 12 months after enrollment
The economic burden
hospitalization cost of the studied population for the last visit; total cost and hospitalization cost of the studied population from 2008 to 2018.
Measured: 12 months after enrollment
Numbers of admissions
The total number of admissions for inpatients from 2008 to 2018
Measured: 12 months after enrollment
The proportion of re-hospitalization
The last visiting and previous one within 30 days and 90 days
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start28 Feb 2021
- Primary completion28 Oct 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular AbnormalitiesStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Xin, West China Hospital
- Investigators
- Xin Sun, PhD, Study director, The West China Hospital of Sichuan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958760
- Sponsor's protocol ID
- CREAT-DIABETES
- Status last verified
- Jun 2023
- First submitted
- 22 Apr 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03958760
- Acronym / sponsor ID
- CREAT-DIABETES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200,000 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- estimate the proportion of Chinese diabetic/non-diabetic patients with established cardiovascular disease, CKD, or at high cardiovascular risk including hypertension and hyperlipidaemia;
- describe the demographic and clinical characteristics of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;
- investigate the treatment patterns of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;
- examine economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;
- explore the trends of clinical characteristics, treatment pattern, economic burden of inpatients over time (2008, 2013, and 2018 separately);
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetic/non-diabetic patients with/without established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk in TianJin regional database
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
The number of patients with different treatment pattern
Time frame: 10 months after enrollment
The length of stay in the hospital
Time frame: 12 months after enrollment
The economic burden
Time frame: 12 months after enrollment
Numbers of admissions
Time frame: 12 months after enrollment
The proportion of re-hospitalization
Time frame: 12 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Abnormalities
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Sun, PhD study director
The West China Hospital of Sichuan university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Abnormalities and Chronic Kidney Diseases, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of diabetic/non-diabetic patients with disease or risk (time frame: 10 months after enrollment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.