A lifetime registry and imaging database for people with heart, kidney, and metabolic conditions
Study on Construction of Whole Lifecycle Cohort, Big Data Management and Clinical Prognosis of Cardio-Renal-Metabolic (CKM) Syndrome
This project will see if creating a long-term clinical and imaging database for adults with heart, kidney, or metabolic conditions can improve prediction of outcomes and guide care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07547098 on ClinicalTrials.gov |
What this trial studies
This single-center observational registry at the First Affiliated Hospital of Fujian Medical University will combine retrospective inpatient records with prospective annual follow-up for up to five years. It will link multi-source hospital data—including diagnoses, laboratory tests, medications, ECG, echocardiography, vascular function tests, carotid and abdominal ultrasound, bone density, coronary CTA and post-processing metrics, and clinical outcomes—using a patient-centered master index. The database will support standardized CKM phenotyping, event adjudication, and repeat-assessment tracking, with a primary outcome of time-to-first cardiorenal composite endpoint. Monthly passive data updates and active yearly follow-up aim to generate real-world evidence for risk stratification and management of cardio-renal-metabolic patients.
Who should consider this trial
Good fit: Adults 18–80 with inpatient records at the First Affiliated Hospital of Fujian Medical University who have cardiovascular, kidney, or metabolic disease (or key tests supporting CKM phenotyping), can provide consent, and can complete follow-up are ideal candidates.
Not a fit: Patients with expected survival under one year, severe cognitive or psychiatric impairment, long-term absence preventing reliable follow-up, or without retrievable hospital identifiers are unlikely to benefit.
Why it matters
Potential benefit: If successful, the registry could improve risk prediction and treatment planning for people with combined heart, kidney, and metabolic conditions.
How similar studies have performed: Separate cardiovascular and renal registries have produced useful risk models and real-world evidence, but integrated lifelong CKM registries are less common and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fuzhou, Fujian
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Dajun Chai — First Affiliated Hospital of Fujian Medical University
- Study coordinator: Dajun Chai
- Email: dajunchai-fy@fjmu.edu.cn
- Phone: 008659187981637
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.