ovel 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 TRIA

DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II0 个研究点目标入组 520 人开始时间: 2021年8月2日最近更新: 2021年8月17日

试验速览

暂无简介。

•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.

发起方

DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II