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Recruiting NCT06336239

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

— Observational Cardiovascular Disease Type 2 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiovascular Disease, Type 2 Diabetes Mellitus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

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.

Primary outcome measures

  • The prevalence of albuminuria [Time frame: On the day of patients enrollment.]
Secondary outcome measures (4)
  • Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria [Time frame: On the day of patients enrollment.]
  • The prevalence of microalbuminuria and macroalbuminuria [Time frame: 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.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 27 centers
  • Beijing Sixth Hospital — Beijing
  • Fangshan District First Hospital — Beijing
  • Peking University Third Hospital — Beijing
  • Chinese PLA Army Characteristic Medical Center — Chongqing
  • Haidong City Second People's Hospital — Haidong
  • The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
  • First Hospital of Hebei Medical University — Shijiazhuang
  • Ruyang County People's Hospita — Luoyang
  • … and 19 more centers

Identifiers

NCT: NCT06336239 · KS2023097

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗