Cardiovascular Diseases (CVD), Cardiovascular-kidney-metabolic Syndrome, Chronic Kidney Disease, Metabolic Diseases
Conditions
Keywords
CKM syndrome, Cardiovascular-Kidney-Metabolic, Patient registry, Real-world data
Brief summary
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.
Detailed 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.
Interventions
None listed
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First occurrence of a cardiorenal composite endpoint | Up to 5 years from enrollment | Time to first occurrence of cardiovascular death or kidney disease progression, defined as sustained decline in eGFR of at least 40% from baseline, sustained eGFR below 15 mL/min/1.73 m², initiation of maintenance dialysis, kidney transplantation, or renal death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | Up to 5 years from enrollment | Time to death from any cause during follow-up. |
| 3-point major adverse cardiovascular events (3-point MACE) | Up to 5 years from enrollment | Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke. |
| First hospitalization for heart failure or cardiovascular death | Up to 5 years from enrollment. | Time to first hospitalization for heart failure or cardiovascular death during follow-up. |
| Nonfatal Myocardial Infarction | Up to 5 years from enrollment | First occurrence of nonfatal myocardial infarction during follow-up. |
| Nonfatal Ischemic Stroke | Up to 5 years from enrollment | First occurrence of nonfatal ischemic stroke during follow-up. |
| Incident Atrial Fibrillation | Up to 5 years from enrollment | New-onset atrial fibrillation among participants without a history of atrial fibrillation at baseline, confirmed by 12-lead electrocardiography, Holter monitoring, or inpatient/outpatient clinical diagnosis during follow-up. |
| Coronary Revascularization | Up to 5 years from enrollment | First occurrence of coronary revascularization, including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), during follow-up. |
| Aortic Disease Intervention | Up to 5 years from enrollment | First occurrence of endovascular or surgical intervention for aortic dissection, aortic aneurysm, penetrating aortic ulcer, or other aortic diseases during follow-up. |
| Peripheral Vascular Events | From enrollment until the date of first documented peripheral vascular event, death, loss to follow-up, or end of study, whichever came first, assessed up to 5 years. | First occurrence of peripheral vascular events, including acute limb ischemia, peripheral arterial revascularization, or major amputation due to vascular causes. |
| Incident Diabetes Mellitus | Up to 5 years from enrollment | New-onset diabetes mellitus among participants without diabetes at baseline, defined as a new clinical diagnosis of diabetes, initiation of glucose-lowering therapy, or laboratory evidence meeting diagnostic criteria during follow-up. |
Countries
China
Contacts
CONTACTDajun Chai
CONTACTHailin Zhang
PRINCIPAL_INVESTIGATORDajun Chai
First Affiliated Hospital of Fujian Medical University
Outcome results
None listed