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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Hospital-based adult CKM-related inpatients at the First Affiliated Hospital of Fujian Medical University with available clinical and multimodal examination data for longitudinal registry follow-up.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

8,000 Participants
are grouped into 1 trial group
Group A: CKM Registry Cohort

Trial outcomes

Primary outcomes

1

First occurrence of a cardiorenal composite endpoint

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.

Time frame
Up to 5 years from enrollment

Secondary outcomes

1

All-cause mortality

Time to death from any cause during follow-up.

Time frame
Up to 5 years from enrollment
2

3-point major adverse cardiovascular events (3-point MACE)

Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke.

Time frame
Up to 5 years from enrollment
3

First hospitalization for heart failure or cardiovascular death

Time to first hospitalization for heart failure or cardiovascular death during follow-up.

Time frame
Up to 5 years from enrollment.
4

Nonfatal Myocardial Infarction

First occurrence of nonfatal myocardial infarction during follow-up.

Time frame
Up to 5 years from enrollment

Other outcomes

1

Incident Malignant Tumor

First occurrence of a newly diagnosed malignant tumor during follow-up.

Time frame
Up to 5 years from enrollment
2

Incident Dementia Based on Clinical Diagnosis Records

First occurrence of newly diagnosed dementia identified from inpatient or outpatient diagnosis records, discharge records, or follow-up verification during longitudinal follow-up.

Time frame
From enrollment until the date of first documented incident dementia, death, loss to follow-up, or end of study, whichever came first, assessed up to 5 years.
3

Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score

Cognitive decline assessed by change from baseline in Montreal Cognitive Assessment (MoCA) total score during longitudinal follow-up; lower scores indicate worse cognitive performance.

Time frame
Baseline and annual follow-up assessments through longitudinal follow-up, assessed up to 5 years.
4

Coronary CTA Imaging Progression

Longitudinal progression of coronary computed tomography angiography findings, including stenosis severity, plaque burden, plaque composition, coronary artery calcium score, CT-QFR, epicardial adipose tissue parameters, and perivascular fat parameters.

Time frame
Up to 5 years from enrollment

Sponsors and contacts

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