OPTI-STEMI is a randomized, non-profit, open label, multicentre phase II trial for the evaluation of new therapeutic strategies to reduce microvascular obstruction and to optimize revascularization in non-culprit stenosis in STEMI myocardial infarction.

Novel therapeutic strategies to reduce coronary microvascular obstruction and to OPTImize non-culprit stenoses revascularization in ST-Elevation acute Myocardial Infarction Randomized, no-profit, open label, multicenter, phase II, clinical trial - OPTI-STEMI TRIAL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005098-29-IT

Enrollment

520

Registered

2021-08-02

Start date

2021-07-09

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) defined by at least one non-culprit stenosis (NCS) with angiographic severity between 30 and 90% MedDRA version: 20.0 Level: LLT Classification code 10007582 Term: Cardiac insufficiency System Organ Class: 100000004849

Interventions

Product Name: Metoprololo Product Code: [NA] Pharmaceutical Form: Infusion INN or Proposed INN: METOPROLOLO CAS Number: 37350-58-6 Current Sponsor code: Trattamento OPTI-STEMI 1 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with STEMI undergoing primary PCI (pPCI) within 12 hours of the onset of symptoms. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 390 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130

Exclusion criteria

Exclusion criteria: a) Age 80 years; b) Cardiogenic shock or systolic blood pressure <100 mmHg or conditions of hemodynamic or electrical instability; c) Severe renal insufficiency (GFR <30 ml / min / 1.73 m2); d) Allergies to any of the drugs administered in the study; e) Claustrophobia (inability to carry out magnetic resonance imaging); f) Pregnancy, breastfeeding, and pregnancy planning; g) Mechanical prostheses (heart and not); h) Presence of pacemakers or ICDs, implants or electronic devices such as insulin pumps or other infusion pumps; i) Permanent atrial fibrillation; j) Severe conduction disorders that require the implantation of a temporary pacemaker; k) Patients with a previous myocardial infarction in the culprit artery site or with previous aorto-coronary bypass surgery; l) Comorbidities or conditions associated with a life expectancy of less than 1 year; m) Inability to understand and sign the informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objective: to test the efficacy and safety of multiple, sequential pharmacological and non-pharmacological treatments to prevent coronary microvascular obstruction (CMVO) at different phase of treatment of the patient with STEMI undergoing primary PCI.;Secondary Objective: - Evaluate new strategies aimed at optimizing the management of non-culprit strictures. For example, if a revascularization guided by functional indices derived from angiography such as the Quantitative Flow Ratio (QFR) is superior to a strategy guided by FFR measured during the elective procedure in terms of repeated revascularization at 1 year of follow-up (OPTI-STEMI MVD ). - Improving the risk stratification of STEMI patients with CMVO and / or non-culprit coronary stenosis, evaluating the diagnostic and prognostic role of biomarkers, previously associated with ischemic heart disease: eg. natriuretic peptides and mitochondrial function markers, etc. (OPTI-STEMI Biomarkers).;Primary end point(s): Efficacy: Extension of CMVO to magnetic resonance imaging (CMR) within 6 days of pPCI Safety: Major cardiovascular events (MACE: death, ventricular malignant arrhythmias, advanced A-V block, cardiogenic shock and reinfarction) in the first 24 hours post pPCI.;Timepoint(s) of evaluation of this end point: 24 hours and 6 days	—

Measure

Time frame

Main Objective: Primary Objective: to test the efficacy and safety of multiple, sequential pharmacological and non-pharmacological treatments to prevent coronary microvascular obstruction (CMVO) at different phase of treatment of the patient with STEMI undergoing primary PCI.;Secondary Objective: - Evaluate new strategies aimed at optimizing the management of non-culprit strictures. For example, if a revascularization guided by functional indices derived from angiography such as the Quantitative Flow Ratio (QFR) is superior to a strategy guided by FFR measured during the elective procedure in terms of repeated revascularization at 1 year of follow-up (OPTI-STEMI MVD ). - Improving the risk stratification of STEMI patients with CMVO and / or non-culprit coronary stenosis, evaluating the diagnostic and prognostic role of biomarkers, previously associated with ischemic heart disease: eg. natriuretic peptides and mitochondrial function markers, etc. (OPTI-STEMI Biomarkers).;Primary end point(s): Efficacy: Extension of CMVO to magnetic resonance imaging (CMR) within 6 days of pPCI Safety: Major cardiovascular events (MACE: death, ventricular malignant arrhythmias, advanced A-V block, cardiogenic shock and reinfarction) in the first 24 hours post pPCI.;Timepoint(s) of evaluation of this end point: 24 hours and 6 days

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy: - Presence of CMVO on magnetic resonance imaging (CMR) within 6 days of pPCI - Extension of the heart attack to CMR within 6 days of pPCI and at 6 months follow-up - Ejection fraction (LVEF) at CMR within 6 days and at 6 months follow-up from the pPCI - Incidence of resolution of the ST segment> 70% after 60 minutes from the pPCI - Incidence of angiographic perfusion score> 9 after pPCI - Difference in post-pPCI IMR and repeated angiography between study and control groups - Composite goal of MACE and new hospitalizations for heart failure at 12 months; Safety: - Door-to-balloon time - Individual components of MACE.;Timepoint(s) of evaluation of this end point: At 6 days and 12 months; 12 months	—

Measure

Time frame

Secondary end point(s): Efficacy: - Presence of CMVO on magnetic resonance imaging (CMR) within 6 days of pPCI - Extension of the heart attack to CMR within 6 days of pPCI and at 6 months follow-up - Ejection fraction (LVEF) at CMR within 6 days and at 6 months follow-up from the pPCI - Incidence of resolution of the ST segment> 70% after 60 minutes from the pPCI - Incidence of angiographic perfusion score> 9 after pPCI - Difference in post-pPCI IMR and repeated angiography between study and control groups - Composite goal of MACE and new hospitalizations for heart failure at 12 months; Safety: - Door-to-balloon time - Individual components of MACE.;Timepoint(s) of evaluation of this end point: At 6 days and 12 months; 12 months

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Countries

Italy

Contacts

Public ContactDipartimento di Scienze Biomediche

Università degli Studi di Napoli Federico II (unina)

emanuele.barbato@unina.it0817462250

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026