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LVOT VTINCT07114978

Prognostic Value of the LVOT VTI in STEMI Patients Undergoing PPCI

An observational study of LVOT VTI and STEMI - ST Elevation Myocardial Infarction (MI), run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To determine whether LVOT VTI < 15 cm predicts the development of in-hospital cardiogenic shock or need for vasopressors in STEMI patients undergoing primary PCI. To assess association of LVOT VTI with other adverse outcomes (in-hospital death, heart failure, arrhythmias, need for mechanical ventilation, prolonged… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Echocardiography
Type of treatment
Medical device
How many people
125 participants
Where
1 siteEgypt
Study dates
1 Aug 2025to Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: The study population will consist of adult patients (aged ≥18 years) diagnosed with acute ST-segment elevation myocardial infarction (STEMI) who are admitted to Assiut University Hospital - Cardiology Department and undergo primary percutaneous coronary intervention (PCI) within 24 hours of symptom onset. Eligible patients will receive transthoracic echocardiography (TTE) including LVOT VTI measurement within the first 24 hours of admission as part of their routine clinical evaluation. Patients will be prospectively enrolled and followed during hospitalization for the occurrence of adverse in-hospital events such as cardiogenic shock, heart failure, arrhythmias, mechanical ventilation, or in-hospital mortality.

Who may be able to join

  • Adult patients (≥18 years), diagnosed with acute STEMI according to current ESC guidelines(3) and undergoing primary PCI within 24 hours of symptom onset.
  • Patients undergo transthoracic echocardiography within 24 hours of admission.

Who cannot join

  • Presence of significant aortic valve disease (e.g., severe aortic stenosis or regurgitation).
  • LVOT obstruction or hypertrophic cardiomyopathy.
  • Poor echocardiographic window.
  • Refusal to participate.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed Khaled Ahmed Abdel Rahman, Resident doctor contact

+201144362234

ahmed99khaled8377@gmail.com

Mohammad Aboelkasem Ali Mousa, Lecturer contact

+20 10 03377083

m_kasem@aun.edu.eg

Egypt1 site
  • Assiut University

    Asyut

    Assiut University, +2088 22080150, vp_grad@aun.edu.eg

Other trials in Egypt

About this study

Official title: Prognostic Value of the Left Ventricular Outflow Tract Velocity-time Integral in Predicting In-hospital Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention

  • To determine whether LVOT VTI < 15 cm predicts the development of in-hospital cardiogenic shock or need for vasopressors in STEMI patients undergoing primary PCI.
  • To assess association of LVOT VTI with other adverse outcomes (in-hospital death, heart failure, arrhythmias, need for mechanical ventilation, prolonged hospital stay).
Read the detailed description

ST-elevation myocardial infarction (STEMI) remains a leading cause of cardiovascular mortality globally, with an estimated incidence of 50-100 cases per 100,000 person and accounting for nearly 30% of acute coronary syndrome (ACS) presentations. Despite advances in reperfusion therapy, in-hospital complications such as cardiogenic shock (CS) and acute heart failure (HF) continue to affect 5-15% of STEMI patients, with CS-associated mortality exceeding 40%.

Primary percutaneous coronary intervention (PCI) is the standard of care in STEMI patients, but also early identification of high-risk patients is crucial to improving outcomes.

Echocardiographic evaluation of left ventricular outflow tract velocity-time integral (LVOT VTI) has gained attention as a dynamic, bedside echocardiographic parameter that reflects stroke volume (SV) and cardiac output (CO). Several studies in critically ill patients and those with heart failure have shown that low LVOT VTI values (<15 cm) are associated with impaired cardiac output and adverse outcomes, including hypotension, vasopressor requirement, and increased mortality. Moreover, in cardiogenic shock, LVOT VTI has demonstrated superior prognostic accuracy compared to conventional measures such as left ventricular ejection fraction (LVEF).

Despite this growing evidence, the prognostic role of LVOT VTI in STEMI patients remains under-investigated. Since STEMI-related LV dysfunction directly impacts stroke volume, LVOT VTI may offer an early, non-invasive indicator of impending hemodynamic deterioration ـــ potentially before clinical signs become evident. Early identification of those high-risk patients mandates careful hemodynamic monitoring and rapid management of any deterioration.

Being tested
Echocardiography
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07114978
Study groupRoleWhat they receive
Group A: LVOT VTI < 15 cmNot described
Receives: Device: Echocardiography
Group B: LVOT VTI ≥ 15 cmNot described
Receives: Device: Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of cardiogenic shock in patients with LVOT VTI < 15 cm

    Cardiogenic shock defined per ESC 2023 criteria (SBP <90 mmHg for ≥30 minutes plus signs of hypoperfusion, or need for vasopressors/inotropic support). Assessed during hospital stay in relation to baseline LVOT VTI.

    Unit of Measure: Percentage of patients (%)

    Measured: Through hospital stay (up to 3 days)

Secondary outcomes (4)
  1. Incidence of acute heart failure in patients with LVOT VTI < 15 cm

    Defined by signs/symptoms requiring intravenous diuretics or ventilatory support, assessed during hospital stay.

    Unit of Measure: Percentage of patients (%)

    Measured: Through hospital stay (up to 3 days)

  2. Incidence of ventricular arrhythmias in patients with LVOT VTI < 15 cm

    Occurrence of sustained VT or VF requiring intervention, assessed through hospital stay.

    Unit of Measure: Percentage of patients (%)

    Measured: Through hospital stay (up to 3 days)

  3. Need for mechanical ventilation in patients with LVOT VTI < 15 cm

    Use of invasive or non-invasive mechanical ventilatory support during hospital stay.

    Unit of Measure: Percentage of patients (%)

    Measured: Through hospital stay (up to 3 days)

  4. Length of hospital stay

    Number of days from admission to discharge. Unit of Measure: Days

    Measured: Through study completion (an average 1 year )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07114978
Sponsor's protocol ID
LVOT VTI in STEMI
Status last verified
Jul 2025
First submitted
21 Jul 2025
Last updated
11 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Aboelkasem Ali Mousa M, Abdelsabour Abdallah M, Shamseddin Mohammad H, Ahmad Aly Youssef A. Early predictors of left ventricular remodeling after primary percutaneous coronary intervention. Egypt Heart J. 2018 Dec;70(4):403-407. doi: 10.1016/j.ehj.2018.05.003. Epub 2018 Aug 24. No abstract available.

    PubMed 30591763
  • Machado GP, Telo GH, de Araujo GN, da Rosa Barbato JP, Amon A, Martins A, Nassif M, Azevedo W, da Silveira AD, Scolari FL, Pagnoncelli A, Goncalves SC, Truesdell AG, Wainstein R, Wainstein M. A combination of left ventricular outflow tract velocity time integral and lung ultrasound to predict mortality in ST elevation myocardial infarction. Intern Emerg Med. 2024 Nov;19(8):2167-2176. doi: 10.1007/s11739-024-03719-z. Epub 2024 Jul 24.

    PubMed 39044051
  • Ochagavia A, Palomo-Lopez N, Fraile V, Zapata L. Hemodynamic monitoring and echocardiographic evaluation in cardiogenic shock. Med Intensiva (Engl Ed). 2024 Oct;48(10):602-613. doi: 10.1016/j.medine.2024.07.001. Epub 2024 Aug 2.

    PubMed 39097480
  • Gentile F, Buoncristiani F, Sciarrone P, Bazan L, Panichella G, Gasparini S, Chubuchny V, Taddei C, Poggianti E, Fabiani I, Petersen C, Lancellotti P, Passino C, Emdin M, Giannoni A. Left ventricular outflow tract velocity-time integral improves outcome prediction in patients with secondary mitral regurgitation. Int J Cardiol. 2023 Dec 1;392:131272. doi: 10.1016/j.ijcard.2023.131272. Epub 2023 Aug 19.

    PubMed 37604287
  • Yuriditsky E, Mitchell OJ, Sibley RA, Xia Y, Sista AK, Zhong J, Moore WH, Amoroso NE, Goldenberg RM, Smith DE, Jamin C, Brosnahan SB, Maldonado TS, Horowitz JM. Low left ventricular outflow tract velocity time integral is associated with poor outcomes in acute pulmonary embolism. Vasc Med. 2020 Apr;25(2):133-140. doi: 10.1177/1358863X19880268. Epub 2019 Nov 10.

    PubMed 31709912
  • Omote K, Nagai T, Iwano H, Tsujinaga S, Kamiya K, Aikawa T, Konishi T, Sato T, Kato Y, Komoriyama H, Kobayashi Y, Yamamoto K, Yoshikawa T, Saito Y, Anzai T. Left ventricular outflow tract velocity time integral in hospitalized heart failure with preserved ejection fraction. ESC Heart Fail. 2020 Feb;7(1):167-175. doi: 10.1002/ehf2.12541. Epub 2019 Dec 18.

    PubMed 31851433
  • Cheong I, Castro VO, Gomez RA, Merlo PM, Tamagnone FM. A modified subcostal view: a novel method for measuring the LVOT VTI. J Ultrasound. 2023 Jun;26(2):429-434. doi: 10.1007/s40477-022-00671-6. Epub 2022 Apr 21.

    PubMed 35449385
  • Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.

    PubMed 37622654
  • Thiele H, Ohman EM, de Waha-Thiele S, Zeymer U, Desch S. Management of cardiogenic shock complicating myocardial infarction: an update 2019. Eur Heart J. 2019 Aug 21;40(32):2671-2683. doi: 10.1093/eurheartj/ehz363.

    PubMed 31274157
  • Vogel B, Claessen BE, Arnold SV, Chan D, Cohen DJ, Giannitsis E, Gibson CM, Goto S, Katus HA, Kerneis M, Kimura T, Kunadian V, Pinto DS, Shiomi H, Spertus JA, Steg PG, Mehran R. ST-segment elevation myocardial infarction. Nat Rev Dis Primers. 2019 Jun 6;5(1):39. doi: 10.1038/s41572-019-0090-3.

    PubMed 31171787

Questions about this trial

What is this clinical trial studying?

An observational study of LVOT VTI and STEMI - ST Elevation Myocardial Infarction (MI), run by Assiut University at 1 site in Egypt.

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 4 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: opening soon, as of the sponsor's last update on 11 Aug 2025. 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 Egypt. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed Khaled Ahmed Abdel Rahman, Resident doctor (+201144362234, ahmed99khaled8377@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of cardiogenic shock in patients with LVOT VTI < 15 cm (time frame: Through hospital stay (up to 3 days)). 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 NCT07114978, which also lists 10 linked publications.

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 11 Aug 2025.

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