Skip to main content
OpenTrials
Completed

NCT Number: NCT06480929

LV Thrombus Screening in Anterior STEMI: Worth it?

Left ventricular (LV) thrombus is more common in patients with anterior ST-elevation myocardial infarction (STEMI) compared to other types of acute myocardial infarction (AMI) and is linked to worse outcomes. Diagnosing LV thrombus remains challenging. Contrast echocardiography (TTE) has potential to improve diagnostic accuracy, affecting treatment strategies involving antithrombotic/anticoagulation therapy.

This study aimed to evaluate the effectiveness of contrast TTE as a routine screening method for detecting LV thrombus in the acute phase of anterior STEMI.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar Tondela Viseu

Viseu, Visey, 3504-509, Portugal

About this study

The advent of primary percutaneous coronary intervention (PCI) has significantly lowered mortality rates associated with acute myocardial infarction (AMI). Despite these advancements, post-infarction complications, including left ventricular (LV) thrombus, continue to negatively impact prognosis. The incidence of LV thrombus has decreased due to improved reperfusion techniques and antithrombotic therapies; however, it remains a significant risk factor for embolic events, with up to a 10% risk of stroke within a year despite anticoagulation therapy. The formation of thrombus post-AMI, particularly in anterior ST-elevation myocardial infarction (STEMI), is driven by endothelial injury, blood stasis due to LV dysfunction, and hypercoagulability from inflammation.

Anterior STEMI, usually caused by occlusion of the left anterior descending artery, often leads to LV apical akinesia and subsequent thrombus formation within 24 hours to two weeks post-AMI. Guidelines recommend routine transthoracic echocardiography (TTE) post-PCI to evaluate LV function and detect early post-infarction mechanical complications and LV thrombus. However, conventional TTE can be limited by operator skill and may miss thrombi, especially in cases with suboptimal images or small/mural thrombi. Advances in ultrasound technology, including contrast agents, have improved diagnostic accuracy for LV thrombus by enhancing LV opacification and endocardial border delineation, thus identifying the characteristic "filling defect" of intracardiac thrombus.

This study aimed to assess the effectiveness of contrast-enhanced TTE as a routine screening method for detecting LV thrombus in the acute phase of anterior STEMI.

A prospective, single-center, randomized controlled trial was conducted with patients admitted for anterior STEMI at Centro Hospitalar de Tondela-Viseu from November 2021 to January 2023. Patients were randomly assigned to a study group (undergoing contrast TTE) or a control group (undergoing conventional TTE). Exclusion criteria included patients under 18, those without echocardiographic or coronary angiographic evaluation, those with cardiogenic shock, known thrombus, or allergic reactions to contrast agents. Contrast TTE utilized the SonoVue ultrasound agent and GE i9 echocardiograph, performed by specialized cardiologists. Data collected included demographic, clinical, and procedural information, with statistical analysis comparing the characteristics and outcomes between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older
  • Admitted due to anterior ST-elevation myocardial infarction

Exclusion criteria

  • Under 18 years old
  • Did not undergo echocardiographic or coronary angiographic evaluation
  • Cardiogenic shock
  • Previously known thrombus
  • Previously known allergic contrast reaction

Treatment and study plan

Contrast TTE procedure, the SonoVue ultrasound agent

Other

The intervention involved using contrast-enhanced transthoracic echocardiography (TTE) to improve the detection of left ventricular thrombus in patients with anterior ST-elevation myocardial infarction (STEMI).

Primary outcomes

  1. left ventricular thrombus

    Time frame: 7 days (time of echoTT)

    Presence or absence of left ventricular thrombus detected via transthoracic echocardiography with or without contrast agent during hospital admission for acute anterior ST-elevation myocardial infarction (STEMI)

Secondary outcomes

  1. anterior/apical aneurysm

    Time frame: 7 days (time of echoTT)

    Presence or absence of anterior/apical aneurysm confirmed by echocardiography with or without contrast agent during hospital admission for acute anterior ST-elevation myocardial infarction (STEMI) and at follow-up visits post discharge

Sponsors and collaborators

Lead sponsor

Centro Hospitalar Tondela-Viseu

Other

Registry information

Official study title

Left Ventricular Thrombus Routine Screening With Contrast Echocardiography in Patients With Anterior ST-elevation Myocardial Infarction: is it Worth it?

Acronym: LVT-CE-AMI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2024
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.