Thrombus of Left VentricleLVT-CE-AMINCT06480929
LV Thrombus Screening in Anterior STEMI: Worth it?
A study testing Contrast TTE procedure, the SonoVue ultrasound agent in people with Thrombus of Left Ventricle and Anterior Wall Myocardial Infarction, run by Centro Hospitalar Tondela-Viseu at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombus of Left Ventricle, Anterior Wall Myocardial Infarction, ST Elevation Myocardial Infarction
- What is being tested?
- Contrast TTE procedure, the SonoVue ultrasound agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- Admitted due to anterior ST-elevation myocardial infarction
Who cannot join
- Under 18 years old
- Did not undergo echocardiographic or coronary angiographic evaluation
- Cardiogenic shock
- Previously known thrombus
- Previously known allergic contrast reaction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thrombus of Left Ventricle, Anterior Wall Myocardial Infarction, ST Elevation Myocardial Infarction, Echocardiography
- Being tested
- Contrast TTE procedure, the SonoVue ultrasound agent
- Medical subject headings
- Anterior Wall Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Role | What they receive |
|---|---|---|
| study group | Active comparator | The study group included all patients admitted on odd numbered days of the month that performed a contrast TTE, Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days (time of echoTT)
Secondary outcomes (1)
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
Measured: 7 days (time of echoTT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Feb 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thrombus of Left VentricleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Tondela-Viseu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joana Maria Laranjeira Correia, Centro Hospitalar Tondela-Viseu
- Investigators
- Joana ML Correia, Principal investigator, 219827419
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480929
- Sponsor's protocol ID
- CHTondelaViseu
- Acronym
- LVT-CE-AMI
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39103940
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Thrombus Routine Screening With Contrast Echocardiography in Patients With Anterior ST-elevation Myocardial Infarction: is it Worth it?
- ClinicalTrials.gov ID
- NCT06480929
- Acronym / sponsor ID
- LVT-CE-AMI / CHTondelaViseu
- Conditions
- Thrombus of Left Ventricle, Anterior Wall Myocardial Infarction, ST Elevation Myocardial Infarction, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centro Hospitalar Tondela-ViseuUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Other: Contrast TTE procedure, the SonoVue ultrasound agentThe study group included all patients admitted on odd numbered days of the month that performed a contrast TTE, |
| control group | No intervention | –The control group included patients admitted on even numbered days and were submitted to a conventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years or older
- Admitted due to anterior ST-elevation myocardial infarction
Key exclusion criteria (5 listed)
- Under 18 years old
- Did not undergo echocardiographic or coronary angiographic evaluation
- Cardiogenic shock
- Previously known thrombus
- Previously known allergic contrast reaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast TTE procedure, the SonoVue ultrasound agentThe 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). | Other | study group |
Primary outcome
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)
1 secondary outcome
anterior/apical aneurysm
Time frame: 7 days (time of echoTT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Derived from this study: PubMed 39103940Correia 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joana ML Correia principal investigator
219827419
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast TTE procedure, the SonoVue ultrasound agent in people with Thrombus of Left Ventricle and Anterior Wall Myocardial Infarction, run by Centro Hospitalar Tondela-Viseu at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular thrombus (time frame: 7 days (time of echoTT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06480929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.