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

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

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.

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.

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.