Prognostic Value of the LVOT VTI in STEMI Patients Undergoing PPCI

NCT ID: NCT07114978

Last Updated: 2025-08-11

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

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-10-31

Brief Summary

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* 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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A: LVOT VTI < 15 cm

Echocardiography

Intervention Type DEVICE

simple, bedsided, non-invasive

Group B: LVOT VTI ≥ 15 cm

Echocardiography

Intervention Type DEVICE

simple, bedsided, non-invasive

Interventions

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Echocardiography

simple, bedsided, non-invasive

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Presence of significant aortic valve disease (e.g., severe aortic stenosis or regurgitation).
2. LVOT obstruction or hypertrophic cardiomyopathy.
3. Poor echocardiographic window.
4. Refusal to participate.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Khaled Ahmed Abdel Rahman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hosam Hasan Ali Mohamed, Professor

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Khaled Ahmed Abdel Rahman, Resident doctor

Role: CONTACT

+201144362234

Mohammad Aboelkasem Ali Mousa, Lecturer

Role: CONTACT

+20 10 03377083

Facility Contacts

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Assiut University

Role: primary

+2088 22080150

References

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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.

Reference Type BACKGROUND
PMID: 30591763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39044051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39097480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37604287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31709912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31851433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35449385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37622654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31274157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31171787 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/39550175/

Lüsebrink, E., Binzenhöfer, L., Adamo, M., Lorusso, R., Mebazaa, A., Morrow, D. A., Price, S., Jentzer, J. C., Brodie, D., Combes, A., \& Thiele, H. (2024). Cardiogenic shock. Lancet (London, England), 404(10466), 2006-2020.

Other Identifiers

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LVOT VTI in STEMI

Identifier Type: -

Identifier Source: org_study_id

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