A Prospective Cohort Study on Prognostic Factors in Patients With Cardiovascular-kidney-metabolic Syndrome

December 26, 2025 updated by: Peking University Third Hospital
Patients with Cardiovascular-kidney-metabolic syndrome (CKM) will be prospectively enrolled. We will conduct comprehensive analyses, including transcriptomics, proteomics, and metabolomics, using various types of samples such as plasma and whole blood. Adenosine stress echocardiography will be monitored to collect a large amount of data. Long-term follow-up will be conducted, and modern information technology will be utilized to analyze the relationship between different biomarkers and prognosis. Combined with clinical data, we will attempt to construct a predictive model for CKM patients to precisely formulate treatment and follow-up strategies. Demographic and basic clinical information of the study subjects will be collected, including age, gender, height, weight, blood pressure, cardiovascular risk factors (smoking history, alcohol consumption history, blood pressure, lipid levels, glycated hemoglobin, fasting blood glucose, etc.), clinical medication use, and coronary angiography images. During follow-up, changes in risk factor-related indicators such as blood pressure, blood glucose, and lipid levels, medication use, inflammatory markers, and stress echocardiography will be recorded. Plasma and whole blood samples will be collected and stored in a biobank managed by a biospecimen management system. The occurrence of major adverse cardiovascular events (MACE) in all enrolled patients during the follow-up period will be statistically analyzed. This cohort study will follow up with patients for at least 3 years using multiple methods (questionnaires, outpatient follow-up, and telephone calls). Changes in indicators such as MACE occurrence, biochemical markers, echocardiography, carotid ultrasound, and stress echocardiography will be recorded.

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.

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.
4526

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 Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third 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

Patients who meet the criteria for Cardiovascular-kidney-metabolic syndrome. Stage 1: Excess or abnormal fat accumulation, such as overweight/obesity, abdominal obesity, or normal function of adipose tissue, without other metabolic risk factors or CKD.

Stage 2: Presence of metabolic risk factors and CKD, such as having metabolic risk factors (hypertriglyceridemia ≥135 mg/dL, hypertension, diabetes, metabolic syndrome) or moderate to high-risk CKD.

Stage 3: Presence of CKM with subclinical CVD, or being at an equivalent level of risk (assessed as high-risk CVD or very high-risk CKD).

Stage 4: Presence of CKM with CVD, with Stage 4a without renal failure; Stage 4b with renal failure.

Description

Inclusion Criteria:

  • 1）Patients who meet the criteria for CKM stages 0-4 were included. 2）Clinical data were complete.

Exclusion Criteria:

  • 1) Presence of infectious diseases during the sample retention period. 2) Presence of autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, vasculitis, etc.

    3) Presence of tumors. 4) Patients with an estimated life expectancy of less than 2 years. 5) Patients with known hypersensitivity to adenosine. 6) Patients who cannot follow up regularly. 7) Pregnant or breastfeeding women, and those participating in other clinical trials.

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
Major adverse cardiovascular event
Time Frame: 3 years
Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and revascularization
3 years

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.
Peking University Third 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.
  • Study Director: Ming Cui, Peking University Third 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.
May 1, 2025

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.
February 28, 2026

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.
June 30, 2027

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 26, 2025

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.
December 26, 2025

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.
January 8, 2026

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.
January 8, 2026

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.
December 26, 2025

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.
March 1, 2025

More Information

Terms related to this study

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.
  • M20250184

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings