Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Etiological Classification of Aortic Stenosis (AS)
研究概览
简要总结
Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making.
South Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.
详细描述
This is a multicenter, retrospective observational study conducted using data from January 1, 2010 to December 31, 2020. The study will include adult patients (≥18 years old) who underwent at least two transthoracic echocardiograms during the study period. Eligible patients will be identified consecutively from each participating institution's echocardiographic and EMR databases. Patients with moderate or severe valvular heart disease (VHD), as defined by guideline-based echocardiographic criteria, will be included in the final analysis.
Patients with congenital heart disease, previous valve surgery at baseline, or incomplete clinical or imaging data will be excluded. The data collected will include demographics, comorbidities, echocardiographic parameters, and clinical outcomes such as mortality and treatment interventions. Particular attention will be paid to disease severity at baseline, rate of progression (from mild to severe), and time to treatment. Treatment patterns, including referral to surgery or transcatheter valve interventions (e.g., TAVI), will also be explored.
Sampling will follow a non-probability, consecutive patient sampling approach, as patients are retrospectively identified based on predefined eligibility criteria. The final sample size is estimated based on precedent data from a previous Korean VHD study that included ~4,000 patients over a 2-month period across 45 centers. Given the 10-year study duration and the number of participating institutions, a larger and more comprehensive sample is expected in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Period: 2010.1.1~2020.12.31
- •Age > 18 years
- •Moderate or severe native VHD (AS, AR, MR and TR)
- •Perform echocardiography more than twice
排除标准
- •Poor image of echocardiography
- •Follow up loss
结局指标
主要结局
Etiological Classification of Aortic Stenosis (AS)
时间窗: January 1, 2010 - December 31, 2020
Classify AS cases retrospectively into degenerative, bicuspid, rheumatic, infective endocarditis, or aortopathy based on clinical records and imaging data.
Prevalence of Moderate and Severe Valvular Heart Disease (VHD)
时间窗: January 1, 2010 - December 31, 2020
Evaluate the prevalence of moderate and severe VHD (including AS, AR, MR, and TR) based on echocardiographic findings and diagnostic records during the study period.
Etiological Classification of Aortic Regurgitation (AR)
时间窗: January 1, 2010 - December 31, 2020
Categorize AR patients according to underlying causes: degenerative, bicuspid, rheumatic, infective endocarditis, or aortopathy.
Etiological Classification of Mitral Regurgitation (MR)
时间窗: January 1, 2010 - December 31, 2020
Retrospectively classify MR into primary MR (degenerative, mitral valve prolapse, rheumatic, endocarditis) and secondary MR (ventricular functional MR, atrial functional MR).
Classification of Tricuspid Regurgitation (TR)
时间窗: January 1, 2010 - December 31, 2020
Classify TR cases into primary and secondary based on echocardiographic findings and clinical context.
Disease Progression and Treatment Pathway
时间窗: January 1, 2010 - December 31, 2020
Analyze the time course of VHD progression from mild to moderate to severe and track the time to intervention (surgical or transcatheter) using retrospective patient records.
次要结局
- All-Cause and Cardiovascular Mortality(From initial diagnosis to date of death or last follow-up (within 2010-2020))
- Treatment Pathway by Disease Severity(From initial diagnosis to date of death or last follow-up (within 2010-2020))
