NCT07114978

Brief 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 hospital stay).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress66%
Aug 2025Oct 2026

First Submitted

Initial submission to the registry

July 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 11, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 21, 2025

Last Update Submit

August 4, 2025

Conditions

Outcome Measures

Primary Outcomes (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 (%)

    Through hospital stay (up to 3 days)

Secondary Outcomes (4)

  • Incidence of acute heart failure in patients with LVOT VTI < 15 cm

    Through hospital stay (up to 3 days)

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

    Through hospital stay (up to 3 days)

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

    Through hospital stay (up to 3 days)

  • Length of hospital stay

    Through study completion (an average 1 year )

Study Arms (2)

Group A: LVOT VTI < 15 cm

Device: Echocardiography

Group B: LVOT VTI ≥ 15 cm

Device: Echocardiography

Interventions

simple, bedsided, non-invasive

Group A: LVOT VTI < 15 cmGroup B: LVOT VTI ≥ 15 cm

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (10)

  • 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: 30591763BACKGROUND
  • 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.

    PMID: 39044051BACKGROUND
  • 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: 39097480BACKGROUND
  • 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.

    PMID: 37604287BACKGROUND
  • 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: 31709912BACKGROUND
  • 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: 31851433BACKGROUND
  • 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: 35449385BACKGROUND
  • 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.

    PMID: 37622654BACKGROUND
  • 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.

    PMID: 31274157BACKGROUND
  • 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.

    PMID: 31171787BACKGROUND

Related Links

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Hosam Hasan Ali Mohamed, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Khaled Ahmed Abdel Rahman, Resident doctor

CONTACT

Mohammad Aboelkasem Ali Mousa, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 11, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-07

Locations