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.
- 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: 20.0Level: LLTClassification code 10007582Term: Cardiac insufficiencySystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-005098-29-IT
- Lead Sponsor
- DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 520
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
a) Age <18 years or> 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method