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NCT Number: NCT07547098

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.

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Key information

Conditions

Cardiovascular Diseases (CVD) Cardiovascular Diseases Cardiovascular-kidney-metabolic Syndrome Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350011, China

Location status: Recruiting

Location contact

Hailin Zhang

CONTACT

[email protected]

008659187981637

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. First occurrence of a cardiorenal composite endpoint

    Time frame: 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 outcomes

  1. All-cause mortality

    Time frame: Up to 5 years from enrollment

    Time to death from any cause during follow-up.

  2. 3-point major adverse cardiovascular events (3-point MACE)

    Time frame: Up to 5 years from enrollment

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

  3. First hospitalization for heart failure or cardiovascular death

    Time frame: Up to 5 years from enrollment.

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

  4. Nonfatal Myocardial Infarction

    Time frame: Up to 5 years from enrollment

    First occurrence of nonfatal myocardial infarction during follow-up.

  5. Nonfatal Ischemic Stroke

    Time frame: Up to 5 years from enrollment

    First occurrence of nonfatal ischemic stroke during follow-up.

  6. Incident Atrial Fibrillation

    Time frame: 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.

  7. Coronary Revascularization

    Time frame: 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.

  8. Aortic Disease Intervention

    Time frame: 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.

  9. Peripheral Vascular Events

    Time frame: 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.

  10. Incident Diabetes Mellitus

    Time frame: 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.

Other outcomes

  1. Incident Malignant Tumor

    Time frame: Up to 5 years from enrollment

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

  2. Incident Dementia Based on Clinical Diagnosis Records

    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.

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

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

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

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

  4. Coronary CTA Imaging Progression

    Time frame: Up to 5 years from enrollment

    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.

  5. Progression of MASLD/Fatty Liver-Related Imaging Phenotypes

    Time frame: Up to 5 years from enrollment

    Longitudinal progression of metabolic dysfunction-associated steatotic liver disease (MASLD) or fatty liver-related imaging phenotypes during follow-up.

  6. Change From Baseline in Mean Carotid Intima-Media Thickness (CIMT)

    Time frame: Baseline and repeat carotid ultrasound assessments during longitudinal follow-up, assessed up to 5 years.

    Longitudinal change from baseline in mean carotid intima-media thickness measured by carotid ultrasound during follow-up.

  7. Change From Baseline in Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline and repeat echocardiographic assessments during longitudinal follow-up, assessed up to 5 years.

    Longitudinal change from baseline in left ventricular ejection fraction measured by echocardiography during follow-up.

  8. Change From Baseline in Left Ventricular Mass Index (LVMI)

    Time frame: Baseline and repeat echocardiographic assessments during longitudinal follow-up, assessed up to 5 years.

    Longitudinal change from baseline in left ventricular mass index measured by echocardiography during follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Dajun Chai

CONTACT

[email protected]

008659187981637

Hailin Zhang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Acronym: CKM-LCBP

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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