NCT06860997

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

February 28, 2025

Last Update Submit

April 24, 2026

Conditions

Keywords

Acute Coronary Syndrome (ACS)Non-ST Elevation Myocardial Infarction (NSTEMI)Unstable AnginaTissue Doppler Imaging (TDI)EchocardiographyS' wave velocityMitral Annular Plane Systolic Excursion (MAPSE)Tricuspid Annular Plane Systolic Excursion (TAPSE)Emergency MedicineDiastolic functionPoint-of-Care Ultrasound (PoCUS)Bedside EchocardiographyCardiac Function AssessmentEarly ACS DetectionRegional Wall Motion AbnormalitiesDiagnostic Accuracy

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

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).

Diagnostic Test: Tissue Doppler Imaging (TDI) S' Wave Echocardiography

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).

Echocardiographic Assessment for Early ACS Detection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial InfarctionNon-ST Elevated Myocardial InfarctionAngina, Unstable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Bastian Rodrigues de Castro, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

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

Locations