NCT04988672

OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Luzerner Kantonsspital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the OPTIMISER Registry is to prospectively and retrospectively collect baseline, clinical and procedural data in patients who present with AMI and are treated with PCI as well as prospectively collect the clinical outcome data. Outcomes will be compared in different clinical subgroups. The impact of PCI in AMI in general as well as cardiovascular outcomes after AMI will be assessed.

Detailed description

* To assess procedural success and clinical outcomes among persons with AMI, who undergo PCI and/ or CABG for AMI (STEMI or NSTEMI) 1. Periprocedural outcomes/ complications, which will be analyzed, represent: final result (e.g. TIMI flow), stent expansion, dissections, perforations, prevalence of thrombus (assessed by angiography and intravascular imaging) 2. Short and long-term clinical outcomes of interest including: new AMI, unstable angina (UA), stent-/scaffold thrombosis, target lesion failure, target vessel revascularization, ischemia driven revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death. * To describe procedural and clinical performance of various balloon, stent and scaffold devices implanted in patients presenting with AMI during the afore mentioned period * To study the impact of different devices and strategies used for lesion preparation and PCI optimization strategies among patients undergoing PCI * To describe early and late angiographic and OCT-findings among coronary artery disease in patients with AMI treated with various metallic stent and scaffold devices * To assess possible predictors for coronary stent implantation or device failure * To evaluate the impact of different antithrombotic regimens on patient clinical outcomes * To study procedural and clinical outcomes among CAD patients requiring hemodynamic support using mechanical devices. * To describe economic implications (cost-effectiveness) of various interventional treatments for CAD.

Conditions

• Myocardial Infarction
• Myocardial Ischemia
• STEMI
• NSTEMI

Timeline

• Start date: 2021-01-01
• Primary completion: 2026-12-31
• Completion: 2030-12-31
• First posted: 2021-08-03
• Last updated: 2023-10-06

Locations

1 site across 1 country: Switzerland