Naples PCI Registry
1 other identifier
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2032
February 23, 2024
February 1, 2024
10.1 years
February 10, 2022
February 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
Study Arms (1)
Coronary artery disease requiring percutaneous coronary intervention
Chronic or acute coronary syndrome requiring percutaneous myocardial revascularization.
Interventions
Percutaneous coronary intervention
Eligibility Criteria
Patients with coronary artery disease undergoing PCI at University of Naples "Federico II".
You may qualify if:
- Clinical evidence of coronary artery disease requiring PCI;
- Age ≥18 years;
- Written informed consent.
You may not qualify if:
- \. Inability to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Advanced Biomedical Sciences
Naples, 80131, Italy
Related Publications (7)
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.
PMID: 26334162BACKGROUNDByrne 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.
PMID: 28831994BACKGROUNDCuisset 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.
PMID: 28831996BACKGROUNDRothwell 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.
PMID: 15639683BACKGROUNDKing 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.
PMID: 15741531BACKGROUNDGarcia-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.
PMID: 29891620BACKGROUNDThygesen 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.
PMID: 22922414BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 10, 2022
First Posted
February 21, 2022
Study Start
March 1, 2022
Primary Completion (Estimated)
March 30, 2032
Study Completion (Estimated)
March 30, 2032
Last Updated
February 23, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share