Patient-oriented educational intervention: APP support
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
79 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 and \<80 years old.
2. Males and females at birth.
3. Baseline LDL-Cholesterol:
* ≥ 130 mg/dl (in statin-naïve patients or who have not followed a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment) or
* ≥110 mg/dl (in patients who have received stable moderate-intensity or low-intensity statin treatment in the 4 weeks prior to enrollment) or
* ≥100 mg/dl (in patients who have received stable treatment with high-intensity statins in the 4 weeks prior to enrollment)
4. Discharged at home
5. Ability to understand the requirements of the study and to provide informed consent
Exclusion Criteria:
1. Patients who have previously received or currently treated with PCSK9i (evolocumab or alirocumab) or siRNA (inclisiran)
2. Unstable clinical status (hemodynamic or electrical instability)
3. Uncontrolled cardiac arrhythmias, defined as recurrent, symptomatic ventricular tachycardia or atrial fibrillation or flutter with rapid ventricular response
4. Severe renal dysfunction, defined by eGFR \< 30 mL/min/1.73 m2
5. Active liver disease or liver dysfunction, reported in the medical record or defined by AST or ALT levels \> 3 times the upper limit of normal.
6. Reported intolerance to statins defined by the following criteria: inability to tolerate at least two different statins; intolerance associated with confirmed and intolerable statin-related adverse effects or significant biomarker abnormalities; improvement/resolution of symptoms or biomarkers following dose decrease or discontinuation; symptoms or changes in biomarkers not attributable to established predispositions.
7. Treatment with systemic steroids or systemic cyclosporine within the past 3 months (e.g., intravenously, intramuscularly, or orally)
8. Known active infection or severe hematologic, metabolic, or endocrine dysfunction as judged by the Investigator.
9. Current inclusion in other pharmacological and non-pharmacological experimental studies.
10. Pregnancy. For women of childbearing potential (age \< 50 years and last menses \<12 months prior to screening) who have not undergone tubal ligation, oophorectomy, or hysterectomy, pregnancy will be excluded from a pregnancy test prior to inclusion in the study.
11. Active neoplasia or very severe disease compromising short-medium term life expectancy.
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.
Primary outcome measure(s)
Number of patients achieving Guideline recommended LDL-Cholesterol goal — 12 month 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.
Trial sites (30)
Facility
City
Region
Status
AOU San Luigi Gonzaga - S.C.D.O. Cardiologia
Orbassano
TO
Ospedale Mauriziano Umberto I - SC Cardiologia
Torino
TO
Ospedale Miulli - U.O.C. Cardiologia - UTIC
Acquaviva delle Fonti
Italy
A.O.U. delle Marche - Cardiologia Ospedaliera e UTIC
Ancona
Italy
Ospedale Civile - U.O.C. di Cardiologia
Arzignano
Italy
Azienda Ospedaliera San Pio-PO G. Rummo - Cardiologia Interventistica e UTIC
Benevento
Italy
ARNAS G. Brotzu - Cardiologia con UTIC
Cagliari
Italy
Azienda Ospedaliera S. Anna e S. Sebastiano - U.O. Cardiologia d'Emergenza con UTIC
Caserta
Italy
Azienda Ospedaliera Cannizzaro - UOC Cardiologia
Catania
Italy
Ospedale Maggiore - U.O. Cardiologia e UTIC
Crema
Italy
PO S. Antonio Abate di Trapani - U.O.C. di Cardiologia, UTIC ed Emodinamica
Erice
Italy
Ospedale Padre Antero Micone - SC Cardiologia - UTIC
Genova
Italy
Ospedale Villa Scassi - ASL 3 Ligure - SC Cardiologia UTIC
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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