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Not yet recruiting NCT07114978

Prognostic Value of the LVOT VTI in STEMI Patients Undergoing PPCI

Observational LVOT VTI STEMI - ST Elevation Myocardial Infarction (MI) Primary Percutaneous Coronary Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echocardiography.
Who it may be relevant to
Registry conditions: LVOT VTI, STEMI - ST Elevation Myocardial Infarction (MI), Primary Percutaneous Coronary Intervention. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

* 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).

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.

Interventions

  • Device Echocardiography
    simple, bedsided, non-invasive

Primary outcome measures

  • Incidence of cardiogenic shock in patients with LVOT VTI < 15 cm [Time frame: Through hospital stay (up to 3 days)]
Secondary outcome measures (4)
  • Incidence of acute heart failure in patients with LVOT VTI < 15 cm [Time frame: Through hospital stay (up to 3 days)]
  • Incidence of ventricular arrhythmias in patients with LVOT VTI < 15 cm [Time frame: Through hospital stay (up to 3 days)]
  • Need for mechanical ventilation in patients with LVOT VTI < 15 cm [Time frame: Through hospital stay (up to 3 days)]
  • Length of hospital stay [Time frame: Through study completion (an average 1 year )]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut University — Asyut

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. PMID 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/ PMID 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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 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 syndrom PMID 37622654

Identifiers

NCT: NCT07114978 · LVOT VTI in STEMI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗