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| Name | Class |
|---|---|
| Novartis Farma S.p.A. | UNKNOWN |
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Cluster Randomized Trial to test the effectiveness of a patient level delivered educational intervention to improve the awareness on the relevance of obtaining LDL cholesterol recommended goals in patients admitted for an acute coronary syndrome, as compared to usual care. Overall, 24 sites (Coronary Care Units) will be included in the study, 12 randomized to the intervention and 12 to usual care. Overall, 240 patients will be enrolled during an acute coronary syndrome hospitalization.
Elevated LDL cholesterol levels are associated with an increased risk of adverse events after an acute coronary syndrome. The higher the LDL cholesterol level at patients' admission for acute coronary syndrome, the greater the intensity of lipid-lowering treatment to be adopted to obtain the greatest benefits in terms of reduction of all-cause and cardiovascular mortality.
Despite European Society of Cardiology guideline recommendations to achieve low LDL cholesterol targets in patients with acute coronary syndrome (halving of baseline LDL cholesterol values and reaching LDL cholesterol values < 55 mg/dl or < 40 mg/dl in the case of a second event within two years of the first), this is unlikely to happen in clinical practice. Recent observational studies, such as the Da Vinci and Santorini, provide important insights into the practical management of lipid-lowering therapy in post-ACS patients in daily clinical practice, showing that only about 20% of high- or very-high-risk patients achieve guideline-recommended targets.
On the other hand, aggressive control of modifiable risk factors could prevent up to 80% of premature deaths related to cardiovascular disease. This underscores the importance of healthcare professionals in maximizing prevention efforts. Improvements in community health could prevent millions of serious cardiovascular events each year if properly implemented.
New therapies, such as PCSK9 inhibitors (monoclonal antibodies) or siRNA (inclisiran), offer an option for further and faster LDL cholesterol reduction during the peri- and post-acute coronary syndrome period, associated with a marked improvement in prognosis.
However, the use of these pharmacological strategies is currently quite limited in clinical practice. Several conditions account for the reduced "adherence" of clinicians and patients to the recommended therapies. Health disparities due to socioeconomic status, age, race, gender and cost, limited access to healthcare, perceived side effects associated with lipid-lowering therapies, health literacy and the presence of comorbidities, are all factors contributing to the suboptimal use of proposed therapies. Furthermore, clinical factors, including failure to identify patients requiring LDL cholesterol reassessment, insufficient monitoring, and clinical inertia have been associated with an insufficient use of lipid-lowering therapies.
Recently, the Italian Association of Hospital Cardiologists published a position paper on the treatment of hypercholesterolemia in patients with acute coronary syndrome. In the document, aimed at achieving the lipid targets outlined in the ESC/EAS 2019 guidelines more quickly than those currently recommended (from 8 weeks of the guidelines to 4 weeks of the Italian Association of Hospital Cardiologists document with a progressive and sustainable approach) and including new therapeutic options to reduce LDL cholesterol levels, a personalized therapeutic intervention based on LDL cholesterol levels at the time of hospital admission was proposed.
As a consequence, implementing lipid-lowering treatments early according to patients' clinical risk and the pharmacological options available to clinicians, while improving patients' awareness of cardiovascular risk, remains one of the primary objectives of the clinical cardiologist in secondary prevention.
Technology can effectively serve as an essential aid in achieving therapeutic targets. The introduction of dedicated applications could facilitate doctor-patient communication. On the basis of this evidence, the investigators designed the present study with the aim to evaluate if an educational intervention to improve the awareness on the relevance of obtaining LDL cholesterol recommended goals in patients with confirmed diagnosis of acute coronary syndrome, as compared to usual care can increase the proportion of patients at LDL cholesterol goal as suggested by 2019 ESC/EAS guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quality-improvement educational intervention | Experimental | Patients included in the interventional arm will be guided to download a smartphone App which will allow them:
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| Usual care | No Intervention | Patients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-oriented educational intervention | Other | APP support |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients achieving Guideline recommended LDL-Cholesterol goal | To compare the rate of patients with acute coronary syndrome who achieve the 2019 European Society of Cardiology/European Atherosclerosis Society guideline recommended LDL-Cholesterol goal (<55 mg/dl or <40 mg/dl in patients with recurrent events in the previous 24 months despite maximal lipid lowering treatment) at 12 months in sites following the interventional education protocol versus those receiving usual care. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-Cholesterol variation | Change in LDL-Cholesterol from baseline. | 12 months |
| Use of Injective Lipid Lowering Therapy | Rate of patients who received PCSK9i inhibitors (monoclonal antibodies) or inclisiran during hospitalization (very fast track) |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death (explorative objective) | Assess the rate of cardiovascular deaths | 12 month |
| New hospitalizations for atherothrombotic events (explorative objective) | Assess the rate of new hospitalizations for atherothrombotic events. |
Inclusion Criteria:
Age ≥18 and <80 years old.
Males and females at birth.
Baseline LDL-Cholesterol:
Discharged at home
Ability to understand the requirements of the study and to provide informed consent
Exclusion Criteria:
Only for sites randomized to the interventional group:
• Patients without a device suitable for App use (eg. Smartphone or tablet) or patients that do not consent to receive push notifications by the App.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonardo De Luca, MD | Contact | +390555101355 | early@heartcarefoundation.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU San Luigi Gonzaga - S.C.D.O. Cardiologia | Orbassano | TO | 10043 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37213800 | Background | De Luca L, Riccio C, Navazio A, Valente S, Cipriani M, Corda M, De Nardo A, Francese GM, Napoletano C, Tizzani E, Roncon L, Caldarola P, Gulizia MM, Gabrielli D, Oliva F, Colivicchi F. ANMCO position paper on the management of hypercholesterolaemia in patients with acute coronary syndrome. Eur Heart J Suppl. 2023 May 18;25(Suppl D):D312-D322. doi: 10.1093/eurheartjsupp/suad100. eCollection 2023 May. | |
| 31504418 |
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Cluster randomized trial
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| 1 month |
| Use of Injective Lipid Lowering Therapy | Rate of patients who received PCSK9i inhibitors (monoclonal antibodies) or inclisiran during hospitalization (very fast track) | 6 month |
| Number of participants with lipid lowering treatments related adverse events | In the eCRF at the 6-month follow-up visit discontinuation of lipid-lowering treatments will be recorded together with side effects most frequently associated with these treatments (e.g., arthralgia, limb pain, flu-like symptoms/malaise, myalgia, back pain, and elevated transaminases). | 6 months |
| Number of participants with lipid lowering treatments related adverse events | In the eCRF at the 12-month follow-up visit discontinuation of lipid-lowering treatments will be recorded together with side effects most frequently associated with these treatments (e.g., arthralgia, limb pain, flu-like symptoms/malaise, myalgia, back pain, and elevated transaminases). | 12 months |
| 12 month |
| All-cause mortality (explorative objective) | Assess the rate of all-cause mortality | 12 month |
| All-cause hospitalizations (explorative objective) | Assess the rate of all-cause hospitalizations | 12 month |
| Ospedale Mauriziano Umberto I - SC Cardiologia | Torino | TO | 10128 | Italy |
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| Ospedale Miulli - U.O.C. Cardiologia - UTIC | Acquaviva delle Fonti | 70021 | Italy |
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| A.O.U. delle Marche - Cardiologia Ospedaliera e UTIC | Ancona | 60122 | Italy |
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| Ospedale Civile - U.O.C. di Cardiologia | Arzignano | 36071 | Italy |
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| Azienda Ospedaliera San Pio-PO G. Rummo - Cardiologia Interventistica e UTIC | Benevento | 82100 | Italy |
|
| ARNAS G. Brotzu - Cardiologia con UTIC | Cagliari | 09134 | Italy |
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| Azienda Ospedaliera S. Anna e S. Sebastiano - U.O. Cardiologia d'Emergenza con UTIC | Caserta | 81100 | Italy |
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| Azienda Ospedaliera Cannizzaro - UOC Cardiologia | Catania | 95126 | Italy |
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| Ospedale Maggiore - U.O. Cardiologia e UTIC | Crema | 26013 | Italy |
|
| PO S. Antonio Abate di Trapani - U.O.C. di Cardiologia, UTIC ed Emodinamica | Erice | 91016 | Italy |
|
| Ospedale Padre Antero Micone - SC Cardiologia - UTIC | Genova | 16100 | Italy |
|
| Ospedale Villa Scassi - ASL 3 Ligure - SC Cardiologia UTIC | Genova | 16149 | Italy |
|
| Ospedali Riuniti - U.O.C. Cardiologia e UTIC | Livorno | 57124 | Italy |
|
| ASST Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica | Milan | 20162 | Italy |
|
| Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia | Monza | 20900 | Italy |
|
| AORN Cardarelli - U.O. Cardiologia con UTIC | Naples | 80131 | Italy |
|
| AOR Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello | Palermo | 90146 | Italy |
|
| AOR Villa Sofia-Cervello PO Villa Sofia - UOC Cardiologia e UTIC e Emodinamica-Villa Sofia | Palermo | 90146 | Italy |
|
| Fondazione IRCCS Policlinico San Matteo - UOC Cardiologia | Pavia | 27100 | Italy |
|
| Ospedale Santo Spirito - Cardiologia con UTIC | Pescara | 65124 | Italy |
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| Ospedale Civile Guglielmo da Saliceto - UOC Cardiologia e UTIC | Piacenza | 29100 | Italy |
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| Ospedale Santo Stefano - U.O. Cardiologia | Prato | 59100 | Italy |
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| PO Santa Maria Nuova - AUSL RE IRCCS - SOC Cardiologia Ospedaliera | Reggio Emilia | 42100 | Italy |
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| P.O. San Filippo Neri - ASL ROMA 1 - Cardiologia Clinica e Riabilitativa | Roma | 00135 | Italy |
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| Ospedale San Camillo - UOC Cardiologia | Roma | 00152 | Italy |
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| Policlinico Casilino - U.O.C. Cardiologia | Roma | 00169 | Italy |
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| AOU S. Giovanni Di Dio-Ruggi D'Aragona - SSD UTIC | Salerno | 84131 | Italy |
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| Ospedale SS. Annunziata - Cardiologia Clinica ed Interventistica | Sassari | 07100 | Italy |
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| Ospedale Belcolle - UOSD UTIC Polo | Viterbo | 01100 | Italy |
|
| Background |
| Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available. |
| 33580789 | Background | Ray KK, Molemans B, Schoonen WM, Giovas P, Bray S, Kiru G, Murphy J, Banach M, De Servi S, Gaita D, Gouni-Berthold I, Hovingh GK, Jozwiak JJ, Jukema JW, Kiss RG, Kownator S, Iversen HK, Maher V, Masana L, Parkhomenko A, Peeters A, Clifford P, Raslova K, Siostrzonek P, Romeo S, Tousoulis D, Vlachopoulos C, Vrablik M, Catapano AL, Poulter NR; DA VINCI study. EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study. Eur J Prev Cardiol. 2021 Sep 20;28(11):1279-1289. doi: 10.1093/eurjpc/zwaa047. |
| 37090089 | Background | Ray KK, Haq I, Bilitou A, Manu MC, Burden A, Aguiar C, Arca M, Connolly DL, Eriksson M, Ferrieres J, Laufs U, Mostaza JM, Nanchen D, Rietzschel E, Strandberg T, Toplak H, Visseren FLJ, Catapano AL; SANTORINI Study Investigators. Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study. Lancet Reg Health Eur. 2023 Apr 5;29:100624. doi: 10.1016/j.lanepe.2023.100624. eCollection 2023 Jun. |
| 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. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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