Prognostic Value of the LVOT VTI in STEMI Patients Undergoing PPCI

Not yet recruiting

• Conditions: Primary Percutaneous Coronary Intervention; LVOT VTI; STEMI - ST Elevation Myocardial Infarction (MI)

• Registration Number: NCT07114978
• Lead Sponsor: Assiut University

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).

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-08
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cardiogenic shock in patients with LVOT VTI < 15 cm	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 Outcome Measures

Name	Time	Method
Incidence of acute heart failure in patients with LVOT VTI < 15 cm	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 (%)
Incidence of ventricular arrhythmias in patients with LVOT VTI < 15 cm	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 (%)
Need for mechanical ventilation in patients with LVOT VTI < 15 cm	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 (%)
Length of hospital stay	Through study completion (an average 1 year )	Number of days from admission to discharge. Unit of Measure: Days

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt