Acute Coronary Syndrome, Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention
Conditions
Keywords
Percutaneous coronary intervention, Coronary artery disease
Brief summary
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
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).
Interventions
DEVICEPCI
Percutaneous coronary intervention
Sponsors
Federico II University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical evidence of coronary artery disease requiring PCI; 2. Age ≥18 years; 3. Written informed consent.
Exclusion criteria
1\. Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with target-vessel revascularization | 12 months | Target vessel revascularization |
| Number of patients with target-lesion revascularization | 12 months | Target lesion revascularization |
| Number of patients with contrast-induced acute kidney injury | 12 months | Contrast-induced acute kidney injury |
| Number of patients with bleeding | 12 months | Bleeding |
| Number of patients with death | 12 months | Death |
| Number of patients with myocardial infarction | 12 months | Myocardial infarction |
| Number of patients with stroke | 12 months | Stroke |
| Number of patients with stent thrombosis | 12 months | Stent thrombosis |
Countries
Italy
Contacts
Primary ContactGiovanni Esposito, MD, PhD
Backup ContactRaffaele Piccolo, MD, PhD
Outcome results
None listed