NCT06480929

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

2.1 years

First QC Date

June 21, 2024

Last Update Submit

June 25, 2024

Conditions

Thrombus of Left VentricleAnterior Wall Myocardial InfarctionST Elevation Myocardial InfarctionEchocardiography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • anterior/apical aneurysm

    7 days (time of echoTT)

Study Arms (2)

study group

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

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

Interventions

Contrast TTE procedure, the SonoVue ultrasound agentOTHER

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).

study group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Tondela Viseu

Viseu, Visey, 3504-509, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 39103940DERIVED

MeSH Terms

Conditions

Anterior Wall Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Joana ML Correia

    219827419

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 21, 2024

First Posted

June 28, 2024

Study Start

February 1, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

PT(1)