Savigliano

Researchers are evaluating a cardiogenic shock protocol designed to improve communication and collaboration among hospitals to timely refer cardiogenic shock patients from spoke to hub centres in the Turin and Milan metropolitan areas. This observational study includes both a retrospective cohort from 2016 to 2019 and a prospective cohort starting in 2024. The purpose is to assess whether implementing this dedicated protocol reduces in-hospital or 30-day mortality in patients with acute myocardial infarction complicated by cardiogenic shock AMICS. Cardiogenic shock is a critical condition requiring rapid intervention and specialized care, and the study focuses on improving outcomes by optimizing patient transfer and treatment coordination. The study compares two groups one retrospective group of patients admitted before the protocol was implemented, and one prospective group admitted after the protocol adoption. Patients in the prospective cohort are managed under a standardized communication and referral protocol between spoke and hub centres, which include advanced cardiac interventions such as percutaneous mechanical circulatory support and prompt transfer to specialized teams. Hub centres have multidisciplinary shock teams, cardiac surgery backup, and 247 availability of cardiac care services. Spoke centres provide initial care and stabilization. The study involves 16 centres, with four hubs each receiving patients from three spoke centres. Participants will be monitored during their hospital stay and followed up to 30 days from admission. Data collected include clinical characteristics, treatments, timing of mechanical support device insertion, adverse events, and outcomes like mortality, stroke, bleeding, renal replacement therapy, vascular complications, and myocardial infarction. The study uses electronic health records and prospectively collected data, with no changes to standard care. The primary measure is 30-day mortality, and secondary outcomes include various clinical events and timing metrics related to treatment support. The study aims to provide insight into whether the hub-and-spoke protocol improves survival and quality of care for cardiogenic shock patients.

Researchers are evaluating the clinical performance and long-term safety of scaffold implantation for patients with coronary artery disease in a real-world regional setting. This observational prospective study involves two networks of centers, including all cath-labs in Emilia-Romagna and centers from the MAGIC retrospective study. Investigators have agreed on specific indications and implantation strategies to ensure consistency across centers. The treatment being studied is the implantation of at least one scaffold device during percutaneous coronary intervention PCI. The study focuses on complete revascularization in patients under 65 years, long lesion revascularization especially in the left anterior descending artery, and spontaneous coronary dissection. Implantation strategies include mandatory predilation, precise sizing, avoiding vessels outside specific diameter ranges, and mandatory postdilation with a non-compliant balloon. Participants will be enrolled after approval and followed for safety and outcomes, with adverse events monitored continuously by a Data Safety Monitoring Board. All coronary angiographies and interventions are reviewed by an independent core laboratory to assess adherence to implantation techniques. The primary outcome measured is device-oriented cardiac events at one year, with study participation lasting at least one year to ensure follow-up and compliance.