Prognostic Value of the LVOT VTI in STEMI Patients Undergoing PPCI

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

* 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of significant aortic valve disease (e.g., severe aortic stenosis or regurgitation).

LVOT obstruction or hypertrophic cardiomyopathy.

Poor echocardiographic window.

Refusal to participate.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Echocardiography

    Device

    simple, bedsided, non-invasive

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: Group A: LVOT VTI < 15 cm1 intervention
Group B: Group B: LVOT VTI ≥ 15 cm1 intervention

Trial outcomes

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 (%)

Time frame
Through hospital stay (up to 3 days)

Secondary outcomes

1

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

Defined by signs/symptoms requiring intravenous diuretics or ventilatory support, assessed during hospital stay. Unit of Measure: Percentage of patients (%)

Time frame
Through hospital stay (up to 3 days)
2

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

Occurrence of sustained VT or VF requiring intervention, assessed through hospital stay. Unit of Measure: Percentage of patients (%)

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

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

Use of invasive or non-invasive mechanical ventilatory support during hospital stay. Unit of Measure: Percentage of patients (%)

Time frame
Through hospital stay (up to 3 days)
4

Length of hospital stay

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

Time frame
Through study completion (an average 1 year )

Other outcomes

Sponsors and contacts

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