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NCT Number: NCT07114978

Prognostic Value of the LVOT VTI in STEMI Patients Undergoing PPCI

* 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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echocardiography

Device

simple, bedsided, non-invasive

Primary outcomes

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

    Time frame: Through hospital stay (up to 3 days)

    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 (%)

Secondary outcomes

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

    Time frame: Through hospital stay (up to 3 days)

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

    Unit of Measure: Percentage of patients (%)

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

    Time frame: Through hospital stay (up to 3 days)

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

    Unit of Measure: Percentage of patients (%)

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

    Time frame: Through hospital stay (up to 3 days)

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

    Unit of Measure: Percentage of patients (%)

  4. Length of hospital stay

    Time frame: Through study completion (an average 1 year )

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Khaled Ahmed Abdel Rahman, Resident doctor

CONTACT

[email protected]

+201144362234

Mohammad Aboelkasem Ali Mousa, Lecturer

CONTACT

[email protected]

+20 10 03377083

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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