Clinical trial NCT06336239: PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study
Official title: PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Disease
Type 2 Diabetes Mellitus
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.

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.

Primary outcomes:
measure: The prevalence of albuminuria
timeFrame: On the day of patients enrollment.
Secondary outcomes:
measure: Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria
timeFrame: On the day of patients enrollment.
measure: The prevalence of microalbuminuria and macroalbuminuria
timeFrame: On the day of patients enrollment.
measure: To evaluate the related influence factors of albuminuria and the treatment patterns of CKD patients and non-CKD patients in cardiology departments;
timeFrame: On the day of patients enrollment.
measure: Evaluate the management of patients with type 2 diabetes mellitus and cardiovascular disease across different levels of cardiology departments in hospitals.
timeFrame: On the day of patients enrollment.
Other outcomes:
measure: Exploratory Objective
timeFrame: On the day of patients enrollment.
Locations:
city: Beijing
country: China
facility: Beijing Sixth Hospital
state: Beijing
city: Beijing
country: China
facility: Fangshan District First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Chinese PLA Army Characteristic Medical Center
state: Chongqing
city: Haidong
country: China
facility: Haidong City Second People's Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Shijia Zhuang
country: China
facility: First Hospital of Hebei Medical University
state: Hebei
city: Luoyang
country: China
facility: Ruyang County People's Hospita
state: Henan
city: Luoyang
country: China
facility: Luoyang Sixth People's Hospita
state: Henan
city: Yongcheng
country: China
facility: Yongcheng People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhangjiagang
country: China
facility: Zhangjiagang Sixth People's Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Shenyang Ninth People's Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Tenth People's Hospital
state: Liaoning
city: Jining
country: China
facility: Jining First People's Hospital
state: Shandong
city: Tai'an
country: China
facility: Tai'an First People's Hospital
state: Shandong
city: Weihai
country: China
facility: Weihai Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Jing'an District Central Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University Qingpu Branch
state: Shanghai
city: Changzhi
country: China
facility: Qinyuan County People's Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: XI Ail
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chendu
country: China
facility: The Fifth People's Hospital of Sichuan Province
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
Study officials:
affiliation: Beijing Anzhen Hospital
name: Changsheng Ma, Doctor
role: PRINCIPAL_INVESTIGATOR
References: