Naples PCI Registry

Coronary Artery Disease Clinical Trial

Official title:

Naples PCI Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248165
• Other study ID #: 232/18
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: March 30, 2032

Study information

• Verified date: February 2024
• Source: Federico II University
• Contact: Giovanni Esposito, MD, PhD
• Phone: +390817463075
• Email: espogiov[@]unina.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 30, 2032
• Est. primary completion date: March 30, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Device:
• PCI
Percutaneous coronary intervention

Locations

Country	Name	City	State
Italy	Department of Advanced Biomedical Sciences	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Byrne RA, Stone GW, Ormiston J, Kastrati A. Coronary balloon angioplasty, stents, and scaffolds. Lancet. 2017 Aug 19;390(10096):781-792. doi: 10.1016/S0140-6736(17)31927-X. — View Citation

Cuisset T, Verheugt FWA, Mauri L. Update on antithrombotic therapy after percutaneous coronary revascularisation. Lancet. 2017 Aug 19;390(10096):810-820. doi: 10.1016/S0140-6736(17)31936-0. — View Citation

Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289. — View Citation

King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M, Sibbald B, Lai R. Impact of participant and physician intervention preferences on randomized trials: a systematic review. JAMA. 2005 Mar 2;293(9):1089-99. doi: 10.1001/jama.293.9.1089. — View Citation

Piccolo R, Giustino G, Mehran R, Windecker S. Stable coronary artery disease: revascularisation and invasive strategies. Lancet. 2015 Aug 15;386(9994):702-13. doi: 10.1016/S0140-6736(15)61220-X. — View Citation

Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 2005 Jan 1-7;365(9453):82-93. doi: 10.1016/S0140-6736(04)17670-8. — View 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. — View Citation

Outcome

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