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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKM Registry Cohort | Adults aged 18 to 80 years receiving inpatient care at the First Affiliated Hospital of Fujian Medical University with cardiovascular disease, kidney disease, metabolic disease, or key examination and laboratory data supporting CKM phenotyping, enrolled for structured data collection and longitudinal follow-up. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Time to death from any cause during follow-up. | Up to 5 years from enrollment |
| 3-point major adverse cardiovascular events (3-point MACE) | Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke. |
| Measure | Description | Time Frame |
|---|---|---|
| Incident Malignant Tumor | First occurrence of a newly diagnosed malignant tumor during follow-up. | Up to 5 years from enrollment |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dajun Chai | Contact | 008659187981637 | dajunchai-fy@fjmu.edu.cn | |
| Hailin Zhang | Contact | 824224843@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Dajun Chai | First Affiliated Hospital of Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40671108 | Background | 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. | |
| 41272273 | Background | 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. |
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De-identified individual participant data may be considered for sharing subject to institutional approval, data security requirements, ethics approval where applicable, and the minimum necessary principle. A formal data-sharing policy has not yet been finalized at the time of registration.
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| Up to 5 years from enrollment |
| First hospitalization for heart failure or cardiovascular death | Time to first hospitalization for heart failure or cardiovascular death during follow-up. | Up to 5 years from enrollment. |
| Nonfatal Myocardial Infarction | First occurrence of nonfatal myocardial infarction during follow-up. | Up to 5 years from enrollment |
| Nonfatal Ischemic Stroke | First occurrence of nonfatal ischemic stroke during follow-up. | Up to 5 years from enrollment |
| Incident Atrial Fibrillation | 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. | Up to 5 years from enrollment |
| Coronary Revascularization | First occurrence of coronary revascularization, including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), during follow-up. | Up to 5 years from enrollment |
| Aortic Disease Intervention | First occurrence of endovascular or surgical intervention for aortic dissection, aortic aneurysm, penetrating aortic ulcer, or other aortic diseases during follow-up. | Up to 5 years from enrollment |
| Peripheral Vascular Events | First occurrence of peripheral vascular events, including acute limb ischemia, peripheral arterial revascularization, or major amputation due to vascular causes. | 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 | 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. | Up to 5 years from enrollment |
| 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. |
| 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. | Baseline and annual follow-up assessments through longitudinal follow-up, assessed up to 5 years. |
| 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. | Up to 5 years from enrollment |
| Progression of MASLD/Fatty Liver-Related Imaging Phenotypes | Longitudinal progression of metabolic dysfunction-associated steatotic liver disease (MASLD) or fatty liver-related imaging phenotypes during follow-up. | Up to 5 years from enrollment |
| Change From Baseline in Mean Carotid Intima-Media Thickness (CIMT) | Longitudinal change from baseline in mean carotid intima-media thickness measured by carotid ultrasound during follow-up. | Baseline and repeat carotid ultrasound assessments during longitudinal follow-up, assessed up to 5 years. |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Longitudinal change from baseline in left ventricular ejection fraction measured by echocardiography during follow-up. | Baseline and repeat echocardiographic assessments during longitudinal follow-up, assessed up to 5 years. |
| Change From Baseline in Left Ventricular Mass Index (LVMI) | Longitudinal change from baseline in left ventricular mass index measured by echocardiography during follow-up. | Baseline and repeat echocardiographic assessments during longitudinal follow-up, assessed up to 5 years. |
| 39255681 | Background | 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. |
| 39706244 | Background | 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. |
| 40073760 | Background | 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. |
| 40287685 | Background | 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. |
| 40042920 | Background | 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. |
| 40563333 | Background | 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. |
| 39556396 | Background | Zhu R, Wang R, He J, Wang L, Chen H, Niu X, Sun Y, Guan Y, Gong Y, Zhang L, An P, Li K, Ren F, Xu W, Guo J. Prevalence of Cardiovascular-Kidney-Metabolic Syndrome Stages by Social Determinants of Health. JAMA Netw Open. 2024 Nov 4;7(11):e2445309. doi: 10.1001/jamanetworkopen.2024.45309. |
| 41421989 | Background | Papadakis Z. Exercise in CKM syndrome progression: a stage-specific approach to cardiovascular, metabolic, and renal health. Cardiovasc Diabetol. 2025 Dec 20;24(1):462. doi: 10.1186/s12933-025-03029-4. |
| 39486671 | Background | Kittelson KS, Junior AG, Fillmore N, da Silva Gomes R. Cardiovascular-kidney-metabolic syndrome - An integrative review. Prog Cardiovasc Dis. 2024 Nov-Dec;87:26-36. doi: 10.1016/j.pcad.2024.10.012. Epub 2024 Oct 30. |
| 39160192 | Background | Gao C, Gao S, Zhao R, Shen P, Zhu X, Yang Y, Duan C, Wang Y, Ni H, Zhou L, Xiang Y, Li M, Xu Z, Wang Y, Yang H, Zhao C. Association between systemic immune-inflammation index and cardiovascular-kidney-metabolic syndrome. Sci Rep. 2024 Aug 19;14(1):19151. doi: 10.1038/s41598-024-69819-0. |
| 39705194 | Background | Ferdinand KC. An overview of cardiovascular-kidney-metabolic syndrome. Am J Manag Care. 2024 Dec;30(10 Suppl):S181-S188. doi: 10.37765/ajmc.2024.89670. |
| 40104608 | Background | Javaid A, Hariri E, Ozkan B, Lang K, Khan SS, Rangaswami J, Stone NJ, Blumenthal RS, Ndumele CE. Cardiovascular-Kidney-Metabolic (CKM) Syndrome: A Case-Based Narrative Review. Am J Med Open. 2025 Jan 30;13:100089. doi: 10.1016/j.ajmo.2025.100089. eCollection 2025 Jun. |
| 39932805 | Background | Claudel SE, Schmidt IM, Waikar SS, Verma A. Cumulative Incidence of Mortality Associated with Cardiovascular-Kidney-Metabolic (CKM) Syndrome. J Am Soc Nephrol. 2025 Feb 11;36(7):1343-1351. doi: 10.1681/ASN.0000000637. |
| 38103820 | Background | Sebastian SA, Padda I, Johal G. Cardiovascular-Kidney-Metabolic (CKM) syndrome: A state-of-the-art review. Curr Probl Cardiol. 2024 Feb;49(2):102344. doi: 10.1016/j.cpcardiol.2023.102344. Epub 2023 Dec 14. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009750 | Nutritional and Metabolic Diseases |
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