Ischemic Heart DieaseExercise-EchoNCT07367893
Exercise Echocardiography Registry for Ischemic and Non-Ischemic Heart Disease
An observational study of Ischemic Heart Diease and Non-ischemic Heart Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Heart Diease, Non-ischemic Heart Disease
- How many people
- 10,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2026to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Yongin Severance Hospital
Yongin, Gyeonggi-do, 16995
SungA Bae, 01023273578, cardiobsa@yuhs.ac
About this study
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.
Read the detailed description
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
<Data Collection>
The registry prospectively collects:
- Baseline clinical characteristics, including cardiovascular risk factors and comorbidities
- Indications for exercise echocardiography
- Exercise test parameters, such as exercise modality, workload, blood pressure response, heart rate response, and symptoms during exercise
- Resting and post-exercise echocardiographic measurements, including left ventricular systolic and diastolic function, wall motion, valvular hemodynamics, and pulmonary pressure estimates when available
- Clinically relevant follow-up outcomes obtained through medical record review
<Study Objectives>
The primary objectives of this registry are:
- To characterize exercise-induced echocardiographic responses in patients with ischemic and non-ischemic heart disease
- To assess the association between exercise echocardiographic findings and subsequent clinical outcomes
- To evaluate the prognostic value of exercise echocardiography in real-world clinical practice
<Study Design> This is a non-interventional, observational registry. All clinical evaluations and management decisions are determined by the treating physicians according to standard care. No experimental interventions are introduced as part of this study.
<Significance> By integrating exercise performance, hemodynamic responses, and echocardiographic findings, this registry aims to enhance understanding of the clinical utility of exercise echocardiography across a broad spectrum of heart disease. The results are expected to support improved risk stratification, inform future hypothesis-driven studies, and contribute to evidence-based use of exercise echocardiography in routine cardiovascular care.
- Conditions
- Ischemic Heart Diease, Non-ischemic Heart Disease
- Keywords
- Exercise echocardiography, Ischemic heart disease, non-ischemic heart disease, clinical outcome
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 year
Secondary outcomes (2)
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).
Measured: Up to 1 year
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.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DieaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Hyun Jung, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367893
- Sponsor's protocol ID
- Exercise-Echo Registry
- Acronym
- Exercise-Echo
- Status last verified
- May 2026
- First submitted
- 30 Dec 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Echocardiography Registry for Ischemic and Non-Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT07367893
- Acronym / sponsor ID
- Exercise-Echo / Exercise-Echo Registry
- Conditions
- Ischemic Heart Diease, Non-ischemic Heart Disease
- Keywords
- Exercise echocardiography, Ischemic heart disease, non-ischemic heart disease, clinical outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
<Data Collection>
The registry prospectively collects:
- Baseline clinical characteristics, including cardiovascular risk factors and comorbidities
- Indications for exercise echocardiography
- Exercise test parameters, such as exercise modality, workload, blood pressure response, heart rate response, and symptoms during exercise
- Resting and post-exercise echocardiographic measurements, including left ventricular systolic and diastolic function, wall motion, valvular hemodynamics, and pulmonary pressure estimates when available
- Clinically relevant follow-up outcomes obtained through medical record review
<Study Objectives>
The primary objectives of this registry are:
- To characterize exercise-induced echocardiographic responses in patients with ischemic and non-ischemic heart disease
- To assess the association between exercise echocardiographic findings and subsequent clinical outcomes
- To evaluate the prognostic value of exercise echocardiography in real-world clinical practice
<Study Design> This is a non-interventional, observational registry. All clinical evaluations and management decisions are determined by the treating physicians according to standard care. No experimental interventions are introduced as part of this study.
<Significance> By integrating exercise performance, hemodynamic responses, and echocardiographic findings, this registry aims to enhance understanding of the clinical utility of exercise echocardiography across a broad spectrum of heart disease. The results are expected to support improved risk stratification, inform future hypothesis-driven studies, and contribute to evidence-based use of exercise echocardiography in routine cardiovascular care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in left ventricular ejection fraction (LVEF) measured by transthoracic echocardiography (TTE)
Time frame: 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.
2 secondary outcomes
Composite of cardiovascular death and hospitalization for worsening heart failure (HF) assessed by clinical event adjudication
Time frame: Up to 1 year
Change in exercise capacity (metabolic equivalents, METs) measured by symptom-limited exercise test
Time frame: Baseline and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Diease and Non-ischemic Heart Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SungA Bae, MD., PhD. (+821023273578, cardiobsa@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular ejection fraction (LVEF) measured by transthoracic echocardiography (TTE) (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.