Clinical Echocardiography and S' Wave for Early Recognition of Acute Coronary Syndrome in the Emergency Department, A Prospective Study
CLEAR_ECHO
1 other identifier
interventional
66
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2025
CompletedFirst Submitted
Initial submission to the registry
February 28, 2025
CompletedFirst Posted
Study publicly available on registry
March 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedApril 27, 2026
April 1, 2026
1.2 years
February 28, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Study Arms (1)
Echocardiographic Assessment for Early ACS Detection
OTHERThis 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).
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bastian Rodrigues de Castro, MD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2025
First Posted
March 6, 2025
Study Start
January 12, 2025
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
April 27, 2026
Record last verified: 2026-04