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Recruiting NCT07547098

Study on Construction of Whole Lifecycle Cohort, Big Data Management and Clinical Prognosis of Cardio-Renal-Metabolic (CKM) Syndrome

Conditions: Cardiovascular Diseases (CVD) Chronic Kidney Disease Metabolic Diseases Cardiovascular-kidney-metabolic Syndrome

Sponsor: First Affiliated Hospital of Fujian Medical University

trial.available_in: БГ
Overview
This is a single-center observational registry study aiming to establish a structured clinical and multimodal imaging database for cardiovascular-kidney-metabolic (CKM) populations and to support lifecycle follow-up and outcome management. Adult patients aged 18-80 years with cardiovascular, kidney, and/or metabolic diseases or key data for CKM phenotyping will be enrolled at the First Affiliated Hospital of Fujian Medical University. The study integrates retrospective data entry and prospective follow-up, including clinical records, laboratory tests, medications, electrocardiography, echocardiography, vascular function assessment, carotid and abdominal ultrasound, bone density, coronary CTA and post-processing data. The primary outcome is the first occurrence of a cardiorenal composite endpoint. Participants will be followed for up to 5 years through active annual follow-up and passive monthly data updates to support risk stratification, real-world evidence generation, and CKM management pathway optimization.
Description
This study is a single-center CKM patient registry with retrospective data entry and prospective lifecycle follow-up. A patient-centered master index will be established primarily on the basis of hospitalization identifiers to integrate multi-source hospital data, including discharge records, diagnoses, laboratory testing, medications, electrocardiography, echocardiography, baPWV/ABI, carotid ultrasound, abdominal ultrasound, bone density, coronary CTA and post-processing metrics, and clinical outcome events. A structured longitudinal database will be created to support standardized phenotyping, event adjudication, and repeat-assessment tracking. The primary objective is to build a dynamic registry platform for CKM-related inpatients and to support long-term follow-up, outcome surveillance, risk stratification, and real-world evidence generation. The study is planned for 5 years, from March 1, 2026 to February 28, 2031, with annual active follow-up and monthly passive data updates. Major outcomes include a time-to-first cardiorenal composite endpoint, all-cause mortality, 3-point major adverse cardiovascular events, heart failure hospitalization or cardiovascular death, and additional pre-specified cardiovascular, renal, metabolic, oncologic, cognitive, and imaging progression outcomes.
Who can participate
Inclusion Criteria: * Age 18 years or older. * Inpatient record available at the First Affiliated Hospital of Fujian Medical University with retrievable identifiers for data linkage. * Cardiovascular disease, kidney disease, metabolic disease, or key examination/laboratory information supporting CKM phenotyping. * Willingness to participate and provision of written informed consent. * Ability to complete baseline assessment and follow-up. * Full civil capacity and ability to understand study information. Exclusion Criteria: * Refusal to provide written informed consent. * Severe psychiatric disease or cognitive impairment precluding participation. * End-stage disease with expected survival less than 1 year. * Long-term absence more than 6 months preventing reliable follow-up. * Participation in another clinical study that may interfere with endpoint adjudication. * Missing key fields preventing linkage of examinations, imaging, and outcomes.
Locations 1
China (1)
The First Affiliated Hospital of Fujian Medical University
Fuzhou , Fujian
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
01.03.2026
Completion date
28.02.2031
Registry ID
NCT07547098
Source
clinicaltrials.gov
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