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| ID | Type | Description | Link |
|---|---|---|---|
| CET Campania 3 86/2023 | Registry Identifier | Naples FED2-ICCU Registry |
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This protocol proposes to prospectively evaluate current epidemiology, pharmacologic and invasive management and clinical outcomes of patients with acute cardiovascular diseases admitted at our ICCU.
This study is designed as a single-center, investigator-initiated prospective observational study. Our ICCU is located at the Department of "Scienze Cardiovascolari, Diagnostica per Immagini, e Rete Tempo Dipendente delle Emergenze Cardiovascolari" of the Azienda Ospedaliera Universitaria Federico II. All scientific activities are performed in the Department of Advanced Biomedical Sciences of the University of Naples Federico II.
This is a prospective observational study which does not include pharmacologic or invasive treatments different from daily and guideline-directed management, but only collects data of patients for research purposes, therefore no specific treatments or procedures are included in this research protocol.
The Clinical Trial Unit at the University of Naples "Federico II" will oversee all study procedures and data management. The study data will be anonymized and managed using REDCap electronic data capture, which is hosted at the University of Naples "Federico II".
Once the patient is admitted to our ICCU, the informed consent will be signed and all data will be collected: demographic, clinical, procedural, therapeutic, and outcome data.
Clinical outcomes will be assessed in the in-hospital period, at 30 days, at 1-year and at the longest available follow-up (telephone or follow-up visit).
Main clinical outcomes will be adjudicated by an independent clinical events committee (CEC).
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| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Number of patients with all-cause mortality | 30 days, 1 year |
| Cardiovascular mortality | Number of patients with cardiovascular mortality | 30 days, 1 year |
| Myocardial infarction | Number of patients with myocardial infarction | 30 days, 1 year |
| Stent thrombosis | Number of patients with stent thrombosis | 30 days, 1 year |
| Stroke | Number of patients with stroke | 30 days, 1 year |
| Heart Failure | Number of patients with heart failure | 30 days, 1 year |
| Hospitalization for heart failure | Number of patients with hospitalization for heart failure | 30 days, 1 year |
| Bleeding | Number of patients with bleeding | 30 days, 1 year |
| Acute kidney injury | Number of patients with acute kidney injury |
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Inclusion Criteria:
Exclusion Criteria:
1) Patients not providing consent to data collection
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All adult patients with acute cardiovascular diseases admitted at our ICCU will be eligible for inclusion in the study, and only those not providing consent to data collection will be excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Gargiulo, MD, PhD | Contact | +39-7462253 | giuseppe.gargiulo1@unina.it | |
| Giovanni Esposito, MD, PhD | Contact | +39-7463075 | espogiov@unina.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Gargiulo, MD, PhD | Department of Advanced Biomedical Sciences | Principal Investigator |
| Giovanni Esposito, MD, PhD | Department of Advanced Biomedical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Advanced Biomedical Sciences, University Federico II of Naples | Recruiting | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37622654 | Background | Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available. | |
| 37622666 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 30 days, 1 year |
| Target vessel revascularization | Number of patients with target vessel revascularization | 30 days, 1 year |
| Target lesion revascularization | Number of patients with target lesion revascularization | 30 days, 1 year |
| Hospital length of stay | Duration of hospitalization in days | 0 to 30 days (or more depending on diration of hospitalization) |
| Metrics of diuretic response and decongestion | Diuresis quantification, weight loss, decongestion score, etc. | 0 to 30 days (or more depending on diration of hospitalization) |
| Poor neurologic outcomes | Number of patients with poor neurologic outcomes | 30 days, 1 year |
| ICCU length of stay | Duration of ICCU hospitalization in days | 0 to 30 days (or more depending on diration of hospitalization) |
| Metrics of need for mechanical circulatory support and vasopressors/inotropes | Need for MCS, MCS type and duration; need for vasopressors/inotropes, vasopressors/inotropes types and duration | 0 to 30 days (or more depending on diration of hospitalization) |
| Quality of life | Quality of life assessment by various scores or questionnaires | 30 days, 1 year |
| Background |
| McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available. |
| 36124872 | Background | Leonardi S, Montalto C, Carrara G, Casella G, Grosseto D, Galazzi M, Repetto A, Tua L, Portolan M, Ottani F, Galvani M, Gentile L, Cardelli LS, De Servi S, Antonelli A, De Ferrari GM, Visconti LO, Campo G; ACS Clinical Governance Programme Investigators. Clinical governance of patients with acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2022 Nov 30;11(11):797-805. doi: 10.1093/ehjacc/zuac106. |
| 36259751 | Background | Nadarajah R, Ludman P, Appelman Y, Brugaletta S, Budaj A, Bueno H, Huber K, Kunadian V, Leonardi S, Lettino M, Milasinovic D, Gale CP; NSTEMI Investigators. Cohort profile: the ESC EURObservational Research Programme Non-ST-segment elevation myocardial infraction (NSTEMI) Registry. Eur Heart J Qual Care Clin Outcomes. 2022 Dec 13;9(1):8-15. doi: 10.1093/ehjqcco/qcac067. |
| 36306949 | Background | De Filippo O, D'Ascenzo F, Wanha W, Leonardi S, Raposeiras Roubin S, Fabris E, Truffa Giachet A, Huczek Z, Gaibazzi N, Ielasi A, Cortese B, Borin A, Nunez-Gil IJ, Ugo F, Marengo G, Bianco M, Barbieri L, Marchini F, Desperak P, Melendo-Viu M, Montalto C, Bruno F, Mancone M, Ferrandez-Escarabajal M, Morici N, Scaglione M, Tuttolomondo D, Gasior M, Mazurek M, Gallone G, Campo G, Wojakowski W, Abu Assi E, Sinagra G, de Ferrari GM. IncidenCe and predictOrs of heaRt fAiLure after acute coronarY Syndrome: The CORALYS registry. Int J Cardiol. 2023 Jan 1;370:35-42. doi: 10.1016/j.ijcard.2022.10.146. Epub 2022 Oct 25. |
| D009203 |
| Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |