- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06860997
Clinical Echocardiography and S' Wave for Early Recognition of Acute Coronary Syndrome in the Emergency Department, A Prospective Study (CLEAR_ECHO)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-luc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Echocardiographic Assessment for Early ACS Detection
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).
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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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity and Specificity of Tissue Doppler Imaging (TDI) S' Wave for Acute Coronary Syndrome (ACS) Diagnosis
Time Frame: 3 months
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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. |
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bastian Rodrigues de Castro, MD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Emergency Medicine
- Echocardiography
- Diagnostic Accuracy
- Unstable Angina
- Acute Coronary Syndrome (ACS)
- Diastolic function
- Non-ST Elevation Myocardial Infarction (NSTEMI)
- Tissue Doppler Imaging (TDI)
- S' wave velocity
- Mitral Annular Plane Systolic Excursion (MAPSE)
- Tricuspid Annular Plane Systolic Excursion (TAPSE)
- Point-of-Care Ultrasound (PoCUS)
- Bedside Echocardiography
- Cardiac Function Assessment
- Early ACS Detection
- Regional Wall Motion Abnormalities
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Infarction
- Necrosis
- Myocardial Ischemia
- Ischemia
- Chest Pain
- Angina Pectoris
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Non-ST Elevated Myocardial Infarction
- Myocardial Infarction
- Acute Coronary Syndrome
- Angina, Unstable
Other Study ID Numbers
- 2024/28OCT/476
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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