LV Thrombus Screening in Anterior STEMI: Worth it?

NCT ID: NCT06480929

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thrombus of Left Ventricle Anterior Wall Myocardial Infarction ST Elevation Myocardial Infarction Echocardiography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

study group

The study group included all patients admitted on odd numbered days of the month that performed a contrast TTE,

Group Type ACTIVE_COMPARATOR

Contrast TTE procedure, the SonoVue ultrasound agent

Intervention Type 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).

control group

The control group included patients admitted on even numbered days and were submitted to a conventional

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centro Hospitalar Tondela-Viseu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joana Maria Laranjeira Correia

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joana ML Correia

Role: PRINCIPAL_INVESTIGATOR

219827419

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Hospitalar Tondela Viseu

Viseu, Visey, Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

References

Explore related publications, articles, or registry entries linked to this study.

Correia JL, Ferreira GRM, Fiuza JG, Almeida MD, Coelho J, Correia E, Correia JM, Moreira D, Craveiro N, Goncalves ML, Neto VD. Left ventricular thrombus routine screening with contrast echocardiography in patients with anterior ST-elevation myocardial infarction: is it worth it? J Cardiovasc Imaging. 2024 Aug 5;32(1):21. doi: 10.1186/s44348-024-00027-0.

Reference Type DERIVED
PMID: 39103940 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHTondelaViseu

Identifier Type: -

Identifier Source: org_study_id