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The association between Cardiovascular Disease (CVD) and Chronic Kidney Disease (CKD) is well established. Traditional risk factors for CVD and CKD are similar, with type 2 diabetes mellitus (T2DM) being the most prevalent risk factor. However, CKD is underdiagnosed and undertreated in patients with CVD. Further understanding of the combination of CKD in CVD patients is important to formulate prevention and treatment strategies for CVD patients and high-risk groups, reduce adverse events in CVD patients, and prevent progression of CKD to End Stage Renal Disease (ESRD).
The PLACARD study will include approximately 3,000 patients presenting to the cardiology department with type 2 diabetes and cardiovascular disease. The aim of this study was to assess the prevalence of proteinuria (urinary ACR) in type 2 diabetic patients with different cardiovascular diseases, both inpatient and outpatient in the cardiology departments of secondary and tertiary hospitals in China. Participants will be recruited at 30 clinical centers for a period of six months.
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| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of albuminuria | To assess the prevalence of albuminuria in patients who are combined with type 2 diabetes mellitus and different cardiovascular diseases in inpatient and outpatient cardiology departments of secondary and tertiary hospitals in China. | On the day of patients enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria | To evaluate the levels of microalbuminuria and macroalbuminuria of patients with type 2 diabetes mellitus (T2DM) in inpatients and outpatients cardiology departments; | On the day of patients enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Objective | To evaluate the prevalence of retinopathy in T2DM patients with different cardiovascular diseases attending inpatient and outpatient cardiology departments in secondary and tertiary hospitals in China. | On the day of patients enrollment. |
Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating women;
Dialysis patients;
Other diseases that lead to elevated albuminuria, such as severe infection, confirmed primary glomerular disease, etc.;
. Malignant tumors being treated (surgery, chemotherapy, radiotherapy or targeted therapy);
Cachexia (CSS score ≥ 5 points);
Severe liver disease (Child- Pugh grade C) ;
Participated in an interventional clinical trial in the past three months.
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This study will adopt a stratified, multi-level, and multi-center strategy for continuous screening to enroll patients who meet all inclusion criteria and none of the exclusion criteria. During the enrollment period, the Clinical Coordinator will communicate with and invite all potential patients attending the selected inpatient wards or the designated outpatient physicians
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Du, Doctor | Contact | 86-10-64420102 | duxinheart@sina.com | |
| Yu Kong, Doctor | Contact | 86-13811901076 |
| Name | Affiliation | Role |
|---|---|---|
| Changsheng Ma, Doctor | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Sixth Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2023 | Feb 29, 2024 |
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| The prevalence of microalbuminuria and macroalbuminuria |
To evaluate the prevalence of microalbuminuria and macroalbuminuria in patients with T2DM complicated with different cardiovascular diseases |
| On the day of patients enrollment. |
| To evaluate the related influence factors of albuminuria and the treatment patterns of CKD patients and non-CKD patients in cardiology departments; | After outpatient patients receive feedback on their renal function tests, assess whether physicians prescribe new relevant medical orders by recording them. Evaluate the treatment patterns for CKD and non-CKD patients in the cardiology department. | On the day of patients enrollment. |
| Evaluate the management of patients with type 2 diabetes mellitus and cardiovascular disease across different levels of cardiology departments in hospitals. | Collect clinical assessment data from patients (including test results and the frequency of these tests over the past year), and assess the management of patient-related risk factors and complications by physicians in hospitals of different levels based on the frequency of testing. | On the day of patients enrollment. |
| Fangshan District First Hospital | Completed | Beijing | Beijing Municipality | China |
| Peking University Third Hospital | Completed | Beijing | Beijing Municipality | China |
| Chinese PLA Army Characteristic Medical Center | Completed | Chongqing | Chongqing Municipality | China |
| Haidong City Second People's Hospital | Not yet recruiting | Haidong | Gansu | China |
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| The First Affiliated Hospital of Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
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| First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
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| Ruyang County People's Hospita | Recruiting | Luoyang | Henan | 471201 | China |
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| Luoyang Sixth People's Hospita | Completed | Luoyang | Henan | China |
| Yongcheng People's Hospital | Completed | Yongcheng | Henan | China |
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
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| Zhangjiagang Sixth People's Hospital | Completed | Zhangjiagang | Jiangsu | China |
| Shenyang Ninth People's Hospital | Recruiting | Shenyang | Liaoning | China |
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| Shenyang Tenth People's Hospital | Active, not recruiting | Shenyang | Liaoning | China |
| Jining First People's Hospital | Not yet recruiting | Jining | Shandong | China |
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| Tai'an First People's Hospital | Completed | Tai’an | Shandong | China |
| Weihai Central Hospital | Not yet recruiting | Weihai | Shandong | China |
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| Jing'an District Central Hospital of Shanghai | Completed | Shanghai | Shanghai Municipality | China |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Zhongshan Hospital Fudan University Qingpu Branch | Recruiting | Shanghai | Shanghai Municipality | China |
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| Qinyuan County People's Hospital | Completed | Changzhi | Shanxi | China |
| Shanxi Bethune Hospital | Recruiting | Taiyuan | Shanxi | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | XI Ail | Shanxi | China |
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| The Fifth People's Hospital of Sichuan Province | Not yet recruiting | Chengdu | Sichuan | China |
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| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | China |
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| Taizhou Central Hospital | Recruiting | Taizhou | Zhejiang | China |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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