LV Thrombus Screening in Anterior STEMI: Worth it? (LVT-CE-AMI)

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

Study Overview

• Status: Completed
• Conditions: ST Elevation Myocardial Infarction; Anterior Wall Myocardial Infarction; Echocardiography; Thrombus of Left Ventricle
• Intervention / Treatment: Other: Contrast TTE procedure, the SonoVue ultrasound agent

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Visey
    • Viseu, Visey, Portugal, 3504-509
      • Centro Hospitalar Tondela Viseu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group; The study group included all patients admitted on odd numbered days of the month that performed a contrast TTE,	Other: Contrast TTE procedure, the SonoVue ultrasound agent; 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).
No Intervention: control group; The control group included patients admitted on even numbered days and were submitted to a conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
left ventricular thrombus	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)	7 days (time of echoTT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anterior/apical aneurysm	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	7 days (time of echoTT)

Collaborators and Investigators

• Sponsor: Centro Hospitalar Tondela-Viseu
• Investigators: Principal Investigator: Joana ML Correia, 219827419

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Thrombosis; Anterior Wall Myocardial Infarction
• Other Study ID Numbers: CHTondelaViseu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data collected during this study will be handled with confidentiality and privacy protection measures in place. Due to the sensitive nature of health information, access to IPD will be restricted to authorized personnel only, in accordance with ethical guidelines and regulatory requirements. Researchers interested in accessing the anonymized data for further analysis or collaboration may contact the principal investigator directly after publication, following established data sharing protocols and agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No