PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study (PLACARD)

April 11, 2024 updated by: Chang sheng Ma, Beijing Anzhen Hospital
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).

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yu Kong, Doctor
  • Phone Number: 86-13811901076

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Sixth Hospital
        • Contact:
          • Lei Dong
      • Beijing, Beijing, China
        • Completed
        • Fangshan District First Hospital
      • Beijing, Beijing, China
        • Completed
        • Peking University Third Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • Completed
        • Chinese PLA Army Characteristic Medical Center
    • Gansu
      • Haidong, Gansu, China
        • Not yet recruiting
        • Haidong City Second People's Hospital
        • Contact:
          • Haiyan Xu
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Chen Liu
    • Hebei
      • Shijia Zhuang, Hebei, China
        • Recruiting
        • First Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Luoyang, Henan, China, 471201
        • Recruiting
        • Ruyang County People's Hospita
        • Contact:
          • Yanna Song
        • Principal Investigator:
          • Litao Wu
      • Luoyang, Henan, China
        • Completed
        • Luoyang Sixth People's Hospita
      • Yongcheng, Henan, China
        • Completed
        • Yongcheng People's Hospital
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Zhanying Han
    • Jiangsu
      • Zhangjiagang, Jiangsu, China
        • Completed
        • Zhangjiagang Sixth People's Hospital
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • Shenyang Ninth People's Hospital
        • Contact:
      • Shenyang, Liaoning, China
        • Active, not recruiting
        • Shenyang Tenth People's Hospital
    • Shandong
      • Jining, Shandong, China
        • Not yet recruiting
        • Jining First People's Hospital
        • Contact:
          • Changjie Ren
      • Tai'an, Shandong, China
        • Completed
        • Tai'an First People's Hospital
      • Weihai, Shandong, China
        • Not yet recruiting
        • Weihai Central Hospital
        • Contact:
          • Yufeng Wang
    • Shanghai
      • Shanghai, Shanghai, China
        • Completed
        • Jing'an District Central Hospital of Shanghai
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Xin Chen, Phd
      • Shanghai, Shanghai, China
        • Recruiting
        • Zhongshan Hospital Fudan University Qingpu Branch
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China
        • Completed
        • Qinyuan County People's Hospital
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • XI Ail, Shanxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'An JiaoTong University
        • Contact:
          • Zuyi Yuan
    • Sichuan
      • Chendu, Sichuan, China
        • Not yet recruiting
        • The Fifth People's Hospital of Sichuan Province
        • Contact:
          • Xiaojuan Zhang
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Yong Peng
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Not yet recruiting
        • The first affiliated hospital of Xinjiang medical university
        • Contact:
          • Xiang Ma
    • Zhejiang
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Age ≥18 years old;
  • Diagnosed T2DM combined with ≥1 CVD (hypertension, coronary heart disease, atrial fibrillation, heart failure);
  • During the data collection period, they went to the outpatient clinic of the cardiology department of the research center, or received treatment in the cardiology department;
  • Ability to self-sign informed consent (electronic /paper).

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of albuminuria
Time Frame: On the day of patients enrollment.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria
Time Frame: On the day of patients enrollment.
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.
The prevalence of microalbuminuria and macroalbuminuria
Time Frame: On the day of patients enrollment.
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;
Time Frame: On the day of patients enrollment.
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.
Time Frame: On the day of patients enrollment.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Objective
Time Frame: On the day of patients enrollment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Investigators

  • Principal Investigator: Changsheng Ma, Doctor, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS2023097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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