Acute Coronary SyndromeCLEAR_ECHONCT06860997
Clinical Echocardiography and S' Wave for Early Recognition of Acute Coronary Syndrome in the Emergency Department, A Prospective Study
A study testing Tissue Doppler Imaging (TDI) S' Wave Echocardiography in people with Acute Coronary Syndrome and Myocardial Infarction (MI), run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The goal of this prospective observational study is to assess the diagnostic accuracy of the tissue Doppler imaging (TDI) S' wave in detecting acute coronary syndrome (ACS) in adult patients presenting to the emergency department (ED) with acute chest pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction (MI), Non-ST Elevation Myocardial Infarction
- What is being tested?
- Tissue Doppler Imaging (TDI) S' Wave Echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Jan 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age ≥18 years
- Presenting to the emergency department (ED) with acute chest pain
- No ST-elevation myocardial infarction (STEMI) on initial ECG
- Requiring continuous cardiac monitoring based on triage decision
- Able to provide informed consent (written consent required)
Who cannot join
- Known pre-existing cardiomyopathy (e.g., hypertrophic cardiomyopathy, dilated cardiomyopathy)
- Severe valvular heart disease
- Left bundle branch block (LBBB) or presence of a pacemaker
- Arrhythmias (e.g., atrial fibrillation, frequent premature ventricular contractions)
- Cardiac arrest or cardiogenic shock at presentation
- Pulmonary hypertension
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- Pericardial effusion or tamponade
- Non-cardiac cause of chest pain suspected as the primary diagnosis
- Language barrier preventing informed consent (study materials available in English, French, and Dutch)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this prospective observational study is to assess the diagnostic accuracy of the tissue Doppler imaging (TDI) S' wave in detecting acute coronary syndrome (ACS) in adult patients presenting to the emergency department (ED) with acute chest pain. This study focuses on patients aged 18 years or older, who require continuous cardiac monitoring but do not show ST-elevation myocardial infarction (STEMI) on their initial ECG.
The main questions it aims to answer are:
- Can TDI S' wave velocity serve as an early diagnostic marker for ACS in the emergency department?
- How does the diagnostic performance of TDI S' compare with other echocardiographic markers (MAPSE, TAPSE, and diastolic parameters such as E, E', A, E/A, E/E')?
- Do demographic factors (age, sex, BMI, echogenicity) influence the diagnostic accuracy of echocardiographic parameters for ACS? If there is a comparison group: Researchers will compare TDI S' wave velocity findings with the final adjudicated diagnosis of ACS (determined after 3 months) to evaluate its sensitivity and specificity.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction (MI), Non-ST Elevation Myocardial Infarction, Unstable Angina, Echocardiography, Tissue Doppler
- Being tested
- Tissue Doppler Imaging (TDI) S' Wave Echocardiography
- Keywords
- Acute Coronary Syndrome (ACS), Non-ST Elevation Myocardial Infarction (NSTEMI), Unstable Angina, Tissue Doppler Imaging (TDI), Echocardiography, S' wave velocity, Mitral Annular Plane Systolic Excursion (MAPSE), Tricuspid Annular Plane Systolic Excursion (TAPSE), Emergency Medicine, Diastolic function, Point-of-Care Ultrasound (PoCUS), Bedside Echocardiography, Cardiac Function Assessment, Early ACS Detection, Regional Wall Motion Abnormalities, Diagnostic Accuracy
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Doppler Imaging (TDI) S' Wave EchocardiographyDiagnostic test
This intervention involves bedside echocardiographic assessment using TDI S' wave velocity to evaluate its diagnostic accuracy for acute coronary syndrome (ACS) in patients presenting with acute chest pain in the emergency department (ED).
| Study group | Role | What they receive |
|---|---|---|
| Echocardiographic Assessment for Early ACS Detection | Other | This arm involves bedside echocardiographic assessment using tissue Doppler imaging (TDI) S' wave velocity to evaluate its diagnostic accuracy for acute coronary syndrome (ACS) in patients presenting with acute chest pain in the emergency department (ED). Receives: Diagnostic Test: Tissue Doppler Imaging (TDI) S' Wave Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Tissue Doppler Imaging (TDI) S' Wave for Acute Coronary Syndrome (ACS) Diagnosis
The study will assess the diagnostic accuracy (sensitivity and specificity) of TDI S' wave velocity in detecting ACS in patients presenting to the emergency department (ED) with acute chest pain.
The reference standard for comparison will be the final ACS diagnosis, determined by an adjudication committee based on a review of medical records, ECG findings, cardiac biomarkers (troponins), and follow-up assessments at 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start12 Jan 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bastian Rodrigues de Castro, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860997
- Sponsor's protocol ID
- 2024/28OCT/476
- Acronym
- CLEAR_ECHO
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Echocardiography and S' Wave for Early Recognition of Acute Coronary Syndrome in the Emergency Department, A Prospective Study
- ClinicalTrials.gov ID
- NCT06860997
- Acronym / sponsor ID
- CLEAR_ECHO / 2024/28OCT/476
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction (MI), Non-ST Elevation Myocardial Infarction, Unstable Angina, Echocardiography, Tissue Doppler
- Keywords
- Acute Coronary Syndrome (ACS), Non-ST Elevation Myocardial Infarction (NSTEMI), Unstable Angina, Tissue Doppler Imaging (TDI), Echocardiography, S' wave velocity, Mitral Annular Plane Systolic Excursion (MAPSE), Tricuspid Annular Plane Systolic Excursion (TAPSE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 12 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 6 Mar 2025 (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.
The goal of this prospective observational study is to assess the diagnostic accuracy of the tissue Doppler imaging (TDI) S' wave in detecting acute coronary syndrome (ACS) in adult patients presenting to the emergency department (ED) with acute chest pain. This study focuses on patients aged 18 years or older, who require continuous cardiac monitoring but do not show ST-elevation myocardial infarction (STEMI) on their initial ECG.
The main questions it aims to answer are:
- Can TDI S' wave velocity serve as an early diagnostic marker for ACS in the emergency department?
- How does the diagnostic performance of TDI S' compare with other echocardiographic markers (MAPSE, TAPSE, and diastolic parameters such as E, E', A, E/A, E/E')?
- Do demographic factors (age, sex, BMI, echogenicity) influence the diagnostic accuracy of echocardiographic parameters for ACS? If there is a comparison group: Researchers will compare TDI S' wave velocity findings with the final adjudicated diagnosis of ACS (determined after 3 months) to evaluate its sensitivity and specificity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiographic Assessment for Early ACS Detection | Other | Diagnostic Test: Tissue Doppler Imaging (TDI) S' Wave EchocardiographyThis arm involves bedside echocardiographic assessment using tissue Doppler imaging (TDI) S' wave velocity to evaluate its diagnostic accuracy for acute coronary syndrome (ACS) in patients presenting with acute chest pain in the emergency department (ED). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Presenting to the emergency department (ED) with acute chest pain
- No ST-elevation myocardial infarction (STEMI) on initial ECG
- Requiring continuous cardiac monitoring based on triage decision
- Able to provide informed consent (written consent required)
Key exclusion criteria (9 listed)
- Known pre-existing cardiomyopathy (e.g., hypertrophic cardiomyopathy, dilated cardiomyopathy)
- Severe valvular heart disease
- Left bundle branch block (LBBB) or presence of a pacemaker
- Arrhythmias (e.g., atrial fibrillation, frequent premature ventricular contractions)
- Cardiac arrest or cardiogenic shock at presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Doppler Imaging (TDI) S' Wave EchocardiographyThis intervention involves bedside echocardiographic assessment using TDI S' wave velocity to evaluate its diagnostic accuracy for acute coronary syndrome (ACS) in patients presenting with acute chest pain in the emergency department (ED). | Diagnostic test | Echocardiographic Assessment for Early ACS Detection |
Primary outcome
Sensitivity and Specificity of Tissue Doppler Imaging (TDI) S' Wave for Acute Coronary Syndrome (ACS) Diagnosis
Time frame: 3 months
The study will assess the diagnostic accuracy (sensitivity and specificity) of TDI S' wave velocity in detecting ACS in patients presenting to the emergency department (ED) with acute chest pain. The reference standard for comparison will be the final ACS diagnosis, determined by an adjudication committee based on a review of medical records, ECG findings, cardiac biomarkers (troponins), and follow-up assessments at 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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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. This study is not recruiting at the moment.
Bastian Rodrigues de Castro, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Doppler Imaging (TDI) S' Wave Echocardiography in people with Acute Coronary Syndrome and Myocardial Infarction (MI), run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 27 Apr 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of Tissue Doppler Imaging (TDI) S' Wave for Acute Coronary Syndrome (ACS) Diagnosis (time frame: 3 months). 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 27 Apr 2026.