NCT06336239

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

27 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

December 27, 2023

Last Update Submit

September 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    On the day of patients enrollment.

Secondary Outcomes (4)

  • Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria

    On the day of patients enrollment.

  • The prevalence of microalbuminuria and macroalbuminuria

    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;

    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.

    On the day of patients enrollment.

Other Outcomes (1)

  • Exploratory Objective

    On the day of patients enrollment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Beijing Sixth Hospital

Beijing, Beijing Municipality, China

RECRUITING

Fangshan District First Hospital

Beijing, Beijing Municipality, China

COMPLETED

Peking University Third Hospital

Beijing, Beijing Municipality, China

COMPLETED

Chinese PLA Army Characteristic Medical Center

Chongqing, Chongqing Municipality, China

COMPLETED

Haidong City Second People's Hospital

Haidong, Gansu, China

NOT YET RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

NOT YET RECRUITING

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Ruyang County People's Hospita

Luoyang, Henan, 471201, China

RECRUITING

Luoyang Sixth People's Hospita

Luoyang, Henan, China

COMPLETED

Yongcheng People's Hospital

Yongcheng, Henan, China

COMPLETED

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

NOT YET RECRUITING

Zhangjiagang Sixth People's Hospital

Zhangjiagang, Jiangsu, China

COMPLETED

Shenyang Ninth People's Hospital

Shenyang, Liaoning, China

RECRUITING

Shenyang Tenth People's Hospital

Shenyang, Liaoning, China

ACTIVE NOT RECRUITING

Jining First People's Hospital

Jining, Shandong, China

NOT YET RECRUITING

Tai'an First People's Hospital

Tai’an, Shandong, China

COMPLETED

Weihai Central Hospital

Weihai, Shandong, China

NOT YET RECRUITING

Jing'an District Central Hospital of Shanghai

Shanghai, Shanghai Municipality, China

COMPLETED

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Zhongshan Hospital Fudan University Qingpu Branch

Shanghai, Shanghai Municipality, China

RECRUITING

Qinyuan County People's Hospital

Changzhi, Shanxi, China

COMPLETED

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

XI Ail, Shanxi, China

NOT YET RECRUITING

The Fifth People's Hospital of Sichuan Province

Chengdu, Sichuan, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

NOT YET RECRUITING

Taizhou Central Hospital

Taizhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Changsheng Ma, Doctor

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Kong, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology

Study Record Dates

First Submitted

December 27, 2023

First Posted

March 28, 2024

Study Start

December 21, 2023

Primary Completion

July 9, 2024

Study Completion

December 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations