Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization (ATRIO-CKM)
Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization (ATRIO-CKM)
Cardiovascular-kidney-metabolic (CKM) syndrome is a systemic disorder characterized by pathophysiological interactions among metabolic risk factors, chronic kidney disease, and the cardiovascular system, leading to multiorgan dysfunction and increased risk of atrial fibrillation, stroke, and heart failure. Atrial cardiomyopathy (ACM) - defined as any structural, contractile, or electrical abnormality of the atria - is an increasingly recognized contributor to cardiovascular morbidity and mortality in this population. Despite growing interest in both conditions, their interplay remains poorly understood, limiting effective preventive strategies and risk-stratification approaches for this high-risk group.
CKM staging offers a practical framework for anticipating ACM onset and progression. Because adiposity-driven inflammation, insulin resistance, hypertension, and early kidney injury act as upstream drivers in CKM, the left atrium becomes an early indicator of hemodynamic load and fibrosis - often preceding sustained atrial fibrillation. Early non-invasive detection of ACM across CKM stages could shift care from treating complications to modifying the underlying substrate.
This prospective observational single-center cohort study aims to phenotype ACM non-invasively across all CKM stages at first diagnosis, using standard 12-lead ECG, advanced transthoracic echocardiography with speckle-tracking, a mechanistically selected biomarker panel (NT-proBNP, MR-proANP, Fetuin-A, FGF23), and cardiac MRI.
Adults aged 18 years or older presenting for cardiovascular evaluation are enrolled and grouped as CKM with ACM (study group) versus CKM without ACM (control group). All participants undergo a single standardized baseline evaluation including clinical examination, 12-lead ECG with Bayés interatrial block grading, comprehensive laboratory panel, and advanced echocardiography including left atrial global longitudinal strain by speckle-tracking.
Primary objective: characterize the relationship between ACM and CKM syndrome stages using non-invasive parameters at first diagnosis. Secondary objectives include assessment of clinical, biological, ECG, and imaging profiles of ACM in CKM; evaluation of left atrial function across CKM stages; examination of Bayés interatrial block correlations and the impact of SGLT2 inhibitors and GLP-1 receptor agonists on left atrial remodeling in HFpEF; and identification of independent ACM risk factors incorporating the full biomarker panel.
Statistical analyses include multivariable logistic regression, biomarker ROC analyses, and penalized regression for derivation of a pragmatic ACM risk score with internal validation. Expected outputs include prevalence estimates, effect sizes for ACM and CKM joint categories, biomarker performance metrics, and a clinic-ready checklist for risk-stratified prevention in outpatient settings.
研究概览
地位
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Mariana M Floria, MD, PhD
- 电话号码:+40722364423
- 邮箱:floria.mariana@umfiasi.ro
研究联系人备份
- 姓名:Maria Mihaela M Godun, MD
- 电话号码:+40755777809
- 邮箱:maria_godun@yahoo.com
学习地点
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Iaşi
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Iași、Iaşi、罗马尼亚、700111
- Internal Medicine Clinic I "Prof. Datcu" - Sf. Spiridon County Emergency Clinical Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Adults aged 18 years or older presenting for cardiovascular evaluation Signed written informed consent Agreement with all protocol requirements
Exclusion Criteria:
- Missing key data for ACM or CKM classification Hemodynamically significant valvular heart disease (greater than moderate severity) Mechanical or biological valve prostheses Temporary or permanent cardiac pacing Psychiatric pathology Thyroid pathology (active or untreated) Known cardiomyopathies (hypertrophic, dilated, restrictive, or infiltrative) Refusal to participate or inability to comply with protocol requirements
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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CKM with ACM
Patients with cardiovascular-kidney-metabolic syndrome and atrial cardiomyopathy, defined by presence of Bayés interatrial block on 12-lead ECG and/or reduced left atrial global longitudinal strain and/or elevated left atrial volume index on echocardiography
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CKM without ACM
Patients with cardiovascular-kidney-metabolic syndrome without atrial cardiomyopathy, serving as the control group
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Prevalence of atrial cardiomyopathy (ACM) across CKM syndrome stages
大体时间:Baseline (single evaluation visit)
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Prevalence of ACM defined by presence of Bayés interatrial block (grade 1 or 2) on 12-lead ECG and/or reduced left atrial global longitudinal strain and/or elevated left atrial volume index on transthoracic echocardiography, across CKM syndrome stages 0-4
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Baseline (single evaluation visit)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Left atrial reservoir strain (LA-GLS %) across CKM syndrome stages assessed by speckle-tracking echocardiography
大体时间:Baseline
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Baseline
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Prevalence and grading of Bayés interatrial block and correlation with CKM-specific variables
大体时间:Baseline
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Baseline
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Distribution of biomarker levels (Fetuin-A, MR-proANP, FGF23, NT-proBNP) across ACM and CKM categories
大体时间:Baseline
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Baseline
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Independent risk factors for ACM in CKM syndrome identified by multivariable logistic regression incorporating clinical, ECG, echocardiographic and biomarker variables
大体时间:Baseline
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Baseline
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合作者和调查者
调查人员
- 研究主任:Marius T Marcu, MD, PhD、Grigore T. Popa University of Medicine and Pharmacy Iasi
- 学习椅:Mugurel C Apetrii, MD, PhD、Grigore T. Popa University of Medicine and Pharmacy Iasi
- 学习椅:Anca E Stefan, MD、Grigore T. Popa University of Medicine and Pharmacy Iasi
- 学习椅:Laura Huiban, MD, PhD、Grigore T. Popa University of Medicine and Pharmacy Iasi
- 学习椅:Alexandru F Oancea, MD、Grigore T. Popa University of Medicine and Pharmacy Iasi
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- ATRIO-CKM
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享支持信息类型
- 研究方案
- 树液
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