Exercise Echocardiography Registry for Ischemic and Non-Ischemic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Change in left ventricular ejection fraction (LVEF) measured by transthoracic echocardiography (TTE)
研究概览
简要总结
Exercise echocardiography is a widely used non-invasive test that evaluates cardiac structure and function during physical stress. It provides important information on myocardial ischemia, cardiac performance, hemodynamic responses, and exercise capacity in patients with a broad range of heart diseases. However, real-world prospective data integrating exercise echocardiographic findings across both ischemic and non-ischemic heart disease remain limited.
This prospective observational registry aims to systematically collect clinical, exercise, and echocardiographic data from patients undergoing clinically indicated exercise echocardiography. The registry includes patients with suspected or established ischemic heart disease as well as those with non-ischemic cardiac conditions, such as cardiomyopathies, heart failure, valvular heart disease, and exercise-related symptoms.
The collected data will be used to evaluate exercise-induced changes in cardiac structure and function, identify phenotypes associated with adverse clinical outcomes, and improve risk stratification in routine clinical practice. The registry is observational in nature and does not alter standard clinical care.
详细描述
Exercise echocardiography is an established diagnostic and prognostic tool in cardiovascular medicine, providing dynamic assessment of myocardial function, hemodynamics, and functional capacity under physiological stress. While its role in ischemic heart disease is well recognized, exercise echocardiography is increasingly used in patients with non-ischemic heart disease, including heart failure, cardiomyopathies, valvular disorders, and unexplained exercise intolerance. Despite its broad clinical application, contemporary prospective real-world registries that comprehensively evaluate exercise echocardiographic findings across both ischemic and non-ischemic heart disease are scarce.
The Exercise Echocardiography Registry for Ischemic and Non-Ischemic Heart Disease is a prospective, observational registry designed to collect standardized clinical, exercise testing, and echocardiographic data from patients undergoing clinically indicated exercise echocardiography at a tertiary care center. Participation in the registry does not require any additional diagnostic procedures beyond routine clinical practice.
<Study Population>
Eligible participants include adult patients referred for exercise echocardiography for evaluation of:
- Suspected or known ischemic heart disease
- Non-ischemic heart disease, including cardiomyopathy, heart failure, valvular heart disease, or structural heart disease
- Exercise-related symptoms such as dyspnea, chest discomfort, or reduced exercise tolerance
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older
- •Patients referred for clinically indicated exercise echocardiography as part of routine clinical care
- •Patients evaluated for suspected or known ischemic heart disease, or non-ischemic heart disease, including but not limited to: Cardiomyopathy, Heart failure, Valvular heart disease, Structural heart disease
- •Ability to perform exercise-based stress testing using treadmill or bicycle protocols
- •Availability of baseline clinical data and interpretable echocardiographic images obtained during rest and exercise
- •Provision of informed consent, or eligibility for consent waiver in accordance with institutional review board approval
排除标准
- •Inability to perform exercise testing due to non-cardiac limitations, such as severe orthopedic, neurologic, or pulmonary conditions
- •Poor echocardiographic image quality that does not allow meaningful interpretation of exercise-induced changes
- •Any condition deemed by the treating physician to make participation inappropriate or unsafe, even within an observational framework
研究组 & 干预措施
Eligible participants include adult patients referred for exercise echocardiography
Eligible participants include adult patients referred for exercise echocardiography for evaluation of:
- Suspected or known ischemic heart disease
- Non-ischemic heart disease, including cardiomyopathy, heart failure, valvular heart disease, or structural heart disease
- Exercise-related symptoms such as dyspnea, chest discomfort, or reduced exercise tolerance
结局指标
主要结局
Change in left ventricular ejection fraction (LVEF) measured by transthoracic echocardiography (TTE)
时间窗: Baseline and 1 year
Left ventricular ejection fraction (LVEF) will be assessed by transthoracic echocardiography (TTE) using the biplane method of disks (modified Simpson's method), and the change from baseline to 1 year will be analyzed.
次要结局
- Composite of cardiovascular death and hospitalization for worsening heart failure (HF) assessed by clinical event adjudication(Up to 1 year)
- Change in exercise capacity (metabolic equivalents, METs) measured by symptom-limited exercise test(Baseline and 1 year)