Naples PCI Registry

NCT ID: NCT05248165

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2032-03-30

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).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Coronary artery disease requiring percutaneous coronary intervention

Chronic or acute coronary syndrome requiring percutaneous myocardial revascularization.

PCI

Intervention Type: DEVICE

Percutaneous coronary intervention

Interventions

PCI

Percutaneous coronary intervention

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Esposito

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Advanced Biomedical Sciences

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanni Esposito, MD, PhD

Role: CONTACT

espogiov@unina.it

+390817463075

Raffaele Piccolo, MD, PhD

Role: CONTACT

rafffaele.piccolo@unina.it

+390817464325

Facility Contacts

Raffaele Piccolo, MD,PhD

Role: primary

rafffaele.piccolo@unina.it

+390817464325

References

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Reference Type: BACKGROUND

PMID: 26334162 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 28831994 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28831996 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15639683 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15741531 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29891620 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22922414 (View on PubMed)

Other Identifiers

232/18

Identifier Type: -

Identifier Source: org_study_id