Cardiovascular DiseasePLACARDNCT06336239
PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study
An observational study of Cardiovascular Disease and Type 2 Diabetes Mellitus, run by Beijing Anzhen Hospital at 27 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Type 2 Diabetes Mellitus
- How many people
- 3,000 participants
- Where
- 27 sitesChina
- Study dates
- 21 Dec 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
27 sites in 1 country.
Yu Kong, Doctor contact
27 sites in 1 country
China27 sites, 17 recruiting
- Recruiting
Beijing Sixth Hospital
Beijing, Beijing Municipality
Lei Dong
- Completed
Fangshan District First Hospital
Beijing, Beijing Municipality
- Completed
Peking University Third Hospital
Beijing, Beijing Municipality
- Completed
Qinyuan County People's Hospital
Changzhi, Shanxi
- Not yet recruiting
The Fifth People's Hospital of Sichuan Province
Chengdu, Sichuan
Xiaojuan Zhang
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Yong Peng
- Completed
Chinese PLA Army Characteristic Medical Center
Chongqing, Chongqing Municipality
- Not yet recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Chen Liu
- Not yet recruiting
Haidong City Second People's Hospital
Haidong, Gansu
Haiyan Xu
- Not yet recruiting
Jining First People's Hospital
Jining, Shandong
Changjie Ren
- Recruiting
Ruyang County People's Hospita
Luoyang, Henan, 471201
Yanna Song
Litao Wu
- Completed
Luoyang Sixth People's Hospita
Luoyang, Henan
- Completed
Jing'an District Central Hospital of Shanghai
Shanghai, Shanghai Municipality
- Not yet recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Xin Chen, Phd, heartmedi@163.com
Xin Chen, Phd
- Recruiting
Zhongshan Hospital Fudan University Qingpu Branch
Shanghai, Shanghai Municipality
Zilong Wang, 18116016189, qy1499@126.com
- Recruiting
Shenyang Ninth People's Hospital
Shenyang, Liaoning
Peng Gao, 18940223349, 35095369@qq.com
- Active, not recruiting
Shenyang Tenth People's Hospital
Shenyang, Liaoning
- Recruiting
First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Le Wang, 18633889597, coronary2012@163.com
- Completed
Tai'an First People's Hospital
Tai’an, Shandong
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Yue Song, 13657218603, song_yu_e@163.com
- Recruiting
Taizhou Central Hospital
Taizhou, Zhejiang
Haipeng Cai, 13867622455, 1917483306@qq.com
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Xiang Ma
- Not yet recruiting
Weihai Central Hospital
Weihai, Shandong
Yufeng Wang
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
XI Ail, Shanxi
Zuyi Yuan
- Completed
Yongcheng People's Hospital
Yongcheng, Henan
- Completed
Zhangjiagang Sixth People's Hospital
Zhangjiagang, Jiangsu
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhanying Han
About this study
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).
Read the 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.
- Conditions
- Cardiovascular Disease, Type 2 Diabetes Mellitus
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day of patients enrollment.
Secondary outcomes (4)
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;
Measured: On the day of patients enrollment.
The prevalence of microalbuminuria and macroalbuminuria
To evaluate the prevalence of microalbuminuria and macroalbuminuria in patients with T2DM complicated with different cardiovascular diseases
Measured: 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.
Measured: 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.
Measured: On the day of patients enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start21 Dec 2023
- Primary completion9 Jul 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang sheng Ma, Beijing Anzhen Hospital
- Investigators
- Changsheng Ma, Doctor, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336239
- Sponsor's protocol ID
- KS2023097
- Acronym
- PLACARD
- Status last verified
- Sep 2024
- First submitted
- 27 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06336239
- Acronym / sponsor ID
- PLACARD / KS2023097
- Conditions
- Cardiovascular Disease, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Kong, Doctor contact
Changsheng Ma, Doctor principal investigator
Beijing Anzhen Hospital
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Type 2 Diabetes Mellitus, run by Beijing Anzhen Hospital at 27 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Du, Doctor (86-10-64420102, duxinheart@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of albuminuria (time frame: On the day of patients enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.