Naples PCI Registry

Study Overview
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Brief Summary
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The aim of the Naples PCI registry is to collect prospective data on baseline clinical, laboratory, and angiographic characteristics of patients undergoing PCI for acute or chronic coronary artery disease. All patients receive clinical follow-up at hospital discharge and at 1-year follow-up with the objective to assess clinical outcomes, including death, cardiovascular death, myocardial infarction, stroke, stent thrombosis, target-lesion and target-vessel revascularization, contrast-induced acute kidney injury, and bleeding events.

Detailed Description
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Percutaneous coronary intervention (PCI) constitutes the most commonly performed therapeutic procedure in cardiovascular medicine and one on the most frequent interventions performed in medicine. Since the introduction of the procedure more than 40 years ago, the safety and efficacy profile of PCI has steadily improved with continuous advances in the technique, equipment, and procedural success. In the late 1980s, the advent of coronary stents favored the widespread adoption of PCI in routine clinical practice by eliminating the risk of periprocedural abrupt closure related to coronary dissection and, as corollary, the need for standby emergent coronary artery bypass grafting. Nowadays, about three out of four patients requiring myocardial revascularization are managed PCI. The objective of this study is to evaluate, within the framework of a prospective registry, the safety and efficacy of PCI by considering all device iterations including stent-based as well as non-stent-based interventions. We will evaluate clinical, laboratory, angiographic data of all patients undergoing PCI at the Federico II University Hospital. Clinical follow-up is collected during hospital stay and at 1-year after PCI. All adverse events are independently adjudicated by a clinical events committee (CEC).

Official Title
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Naples PCI Registry

Conditions
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Coronary Artery Disease, Percutaneous Coronary Intervention, Myocardial Ischemia, Myocardial Infarction, Acute Coronary Syndrome

Intervention / Treatment
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* Device: PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical evidence of coronary artery disease requiring PCI; Age ≥18 years; Written informed consent. Exclusion Criteria: 1. Inability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary artery disease requiring percutaneous coronary intervention<br>Chronic or acute coronary syndrome requiring percutaneous myocardial revascularization. | Device: PCI<br>* Percutaneous coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with death | Death | 12 months | 
| Number of patients with myocardial infarction | Myocardial infarction | 12 months | 
| Number of patients with stroke | Stroke | 12 months | 
| Number of patients with stent thrombosis | Stent thrombosis | 12 months | 
| Number of patients with target-vessel revascularization | Target vessel revascularization | 12 months | 
| Number of patients with target-lesion revascularization | Target lesion revascularization | 12 months | 
| Number of patients with contrast-induced acute kidney injury | Contrast-induced acute kidney injury | 12 months | 
| Number of patients with bleeding | Bleeding | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, Coronary artery disease