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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• First occurrence of a cardiorenal composite endpoint [Срок оценки: Up to 5 years from enrollment]

Вторичные конечные точки (10)

• All-cause mortality [Срок оценки: Up to 5 years from enrollment]
• 3-point major adverse cardiovascular events (3-point MACE) [Срок оценки: Up to 5 years from enrollment]
• First hospitalization for heart failure or cardiovascular death [Срок оценки: Up to 5 years from enrollment.]
• Nonfatal Myocardial Infarction [Срок оценки: Up to 5 years from enrollment]
• Nonfatal Ischemic Stroke [Срок оценки: Up to 5 years from enrollment]
• Incident Atrial Fibrillation [Срок оценки: Up to 5 years from enrollment]
• Coronary Revascularization [Срок оценки: Up to 5 years from enrollment]
• Aortic Disease Intervention [Срок оценки: Up to 5 years from enrollment]
• Peripheral Vascular Events [Срок оценки: 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.]
• Incident Diabetes Mellitus [Срок оценки: Up to 5 years from enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Fujian Medical University — Фучжоу

Публикации

• Duan L, Yang H, Chen Z, Zhao J, Yang J, Cai D. Dietary antioxidants and mortality in early-stage CKM syndrome: insights from NHANES. Nutr Metab (Lond). 2025 Jul 16;22(1):77. doi: 10.1186/s12986-025-00974-5. PMID 40671108
• Chen Q, Zhu Y, Gao J, Ni W, Liu S, Rui F, Bai X, Geng N, Jin R, Sun Y, Chen Y, Fan Z, Wu C, Qi X, Shi J, Li J. Cardiovascular-kidney-metabolic (CKM) syndrome is associated with increased mortality in individuals with metabolic dysfunction-associated steatotic liver disease (MASLD). Commun Med (Lond). 2025 Nov 21;5(1):492. doi: 10.1038/s43856-025-01195-w. PMID 41272273
• Li N, Li Y, Cui L, Shu R, Song H, Wang J, Chen S, Liu B, Shi H, Gao H, Huang T, Gao X, Geng T, Wu S. Association between different stages of cardiovascular-kidney-metabolic syndrome and the risk of all-cause mortality. Atherosclerosis. 2024 Oct;397:118585. doi: 10.1016/j.atherosclerosis.2024.118585. Epub 2024 Aug 30. PMID 39255681
• Rumrill SM, Shlipak MG. The New Cardiovascular-Kidney-Metabolic (CKM) Syndrome: An Opportunity for CKD Detection and Treatment in Primary Care. Am J Kidney Dis. 2025 Apr;85(4):399-402. doi: 10.1053/j.ajkd.2024.09.016. Epub 2024 Dec 18. No abstract available. PMID 39706244
• Chen Y, Wu S, Liu H, Zhong Z, Bucci T, Wang Y, Zhao M, Liu Y, Yang Z, Gue Y, McDowell G, Huang B, Lip GYH. Role of oxidative balance score in staging and mortality risk of cardiovascular-kidney-metabolic syndrome: Insights from traditional and machine learning approaches. Redox Biol. 2025 Apr;81:103588. doi: 10.1016/j.redox.2025.103588. Epub 2025 Mar 7. PMID 40073760
• Zheng Q, Cao Z, Teng J, Lu Q, Huang P, Zhou J. Association between atherogenic index of plasma with all-cause and cardiovascular mortality in individuals with Cardiovascular-Kidney-Metabolic syndrome. Cardiovasc Diabetol. 2025 Apr 26;24(1):183. doi: 10.1186/s12933-025-02742-4. PMID 40287685
• Xie Z, Yu C, Cui Q, Zhao X, Zhuang J, Chen S, Guan H, Li J. Global Burden of the Key Components of Cardiovascular-Kidney-Metabolic Syndrome. J Am Soc Nephrol. 2025 Mar 5;36(8):1572-1584. doi: 10.1681/ASN.0000000658. PMID 40042920
• Guerrero-Mauvecin J, Villar-Gomez N, Mino-Izquierdo L, Povo-Retana A, Ramos AM, Ruiz-Hurtado G, Sanchez-Nino MD, Ortiz A, Sanz AB. Antioxidant Effects of SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic (CKM) Syndrome. Antioxidants (Basel). 2025 Jun 9;14(6):701. doi: 10.3390/antiox14060701. PMID 40563333

Идентификаторы

NCT: NCT07547098 · MRCTA,ECFAH of FMU[2026]046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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