Exercise Echocardiography Registry for Ischemic and Non-Ischemic Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population includes adult patients who undergo clinically indicated exercise echocardiography as part of routine cardiovascular care. Participants are referred for evaluation of suspected or established ischemic heart disease as well as a broad range of non-ischemic heart diseases, including cardiomyopathy, heart failure, valvular heart disease, and structural heart disease. Patients are required to be able to perform exercise-based stress testing using standard treadmill or bicycle protocols and to have interpretable echocardiographic images obtained at rest and during exercise. This registry reflects a real-world clinical population in which exercise echocardiography is used for diagnostic and prognostic assessment across diverse cardiovascular conditions.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 1 trial groupGroup A: Eligible participants include adult patients referred for exercise echocardiography
Trial outcomes
Primary outcomes
1
Change in left ventricular ejection fraction (LVEF) measured by transthoracic echocardiography (TTE)
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.
Time frame
Baseline and 1 yearSecondary outcomes
1
Composite of cardiovascular death and hospitalization for worsening heart failure (HF) assessed by clinical event adjudication
The composite endpoint includes cardiovascular death and hospitalization for worsening heart failure (HF). Events will be identified from medical records and adjudicated according to prespecified criteria (e.g., admission ≥24 hours with primary diagnosis of HF requiring intravenous diuretics/inotropes/vasodilators or mechanical circulatory/ventilatory support).
Time frame
Up to 1 year2
Change in exercise capacity (metabolic equivalents, METs) measured by symptom-limited exercise test
Exercise capacity will be assessed as metabolic equivalents (METs) obtained during a symptom-limited exercise test (e.g., treadmill or cycle ergometer using a standardized protocol). The change in achieved METs from baseline to 1 year will be analyzed.
Time frame
Baseline and 1 yearLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Yonsei University Yongin Severance HospitalRecruiting16995, Yongin, Gyeonggi-doSouth Korea
Sponsors and contacts
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Source ClinicalTrials.gov