Clinical trial NCT05248165: Naples PCI Registry
Official title: Naples PCI Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Myocardial Ischemia
Myocardial Infarction
Acute Coronary Syndrome
Keywords: Percutaneous coronary intervention
Coronary artery disease
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease undergoing PCI at University of Naples "Federico II".

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with death
timeFrame: 12 months
measure: Number of patients with myocardial infarction
timeFrame: 12 months
measure: Number of patients with stroke
timeFrame: 12 months
measure: Number of patients with stent thrombosis
timeFrame: 12 months
measure: Number of patients with target-vessel revascularization
timeFrame: 12 months
measure: Number of patients with target-lesion revascularization
timeFrame: 12 months
measure: Number of patients with contrast-induced acute kidney injury
timeFrame: 12 months
measure: Number of patients with bleeding
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Advanced Biomedical Sciences
Study officials:
References:
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citation: Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.