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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Anzhen Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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