Myocardial Infarction Clinical Trial
— BETA-MIOfficial title:
Modulation of the WNT/Beta-Catenin Pathway in Patients With Acute Myocardial Infarction
NCT number | NCT05122741 |
Other study ID # | Cardio1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2021 |
Est. completion date | December 31, 2023 |
This is a single-center, prospective, observational controlled cohort study designed to describe the role of WNT/B-catenin signaling and adenosine system after an acute myocardial infarction, correlating it with clinical markers of fibrosis/remodeling (primary objective). The modulation of the aforementioned molecular patterns will also be evaluated in light of the type of P2Y12 inhibitor implemented (ticagrelor or prasugrel) to identify variations in response (secondary objective).
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients with ST segment elevation acute myocardial infarction undergoing coronary angiography and interventional treatment.* * Patients with chronic coronary syndrome matched by age, sex and risk factors will also be screened and included as per study design. - Patients with an indication to potent P2Y12 inhibitor therapy (i.e. ticagrelor or prasugrel) for acute myocardial infarction. - Population equally amenable to ticagrelor or prasugrel therapy according to the italian drug instruction of use (IFU) Exclusion Criteria: - Patients with a poor prognosis (less than 12 months) - Patients admitted with cardiogenic shock or advanced cardiac failure (NYHA 4) - Patients pre-treated before coronary angiography or in chronic therapy with a P2Y12 inhibitor - Patients undergoing a medical only approach without percutaneous myocardial revascularization - Patients undergoing surgical coronary revascularization - Patients with prior history of myocardial infarction or prior coronary revascularization. - Patients with contraindications or intolerance to antiplatelet therapy (ticagrelor, prasugrel, clopidogrel or cardioaspirin) - Patients scheduled for a treatment with with cangrelor or GPIIb/IIIa inhibitors - Patients with active bleeding at the time of inclusion - Hemorrhagic diathesis - Confirmed history of renal failure with glomerular filtration rate of <30ml/min - Severe hepatopathy - Patients treated or scheduled for treatment with oral anticoagulant therapy - Active cancer or diagnosis any proliferative disease within 5 years. - Prior TIA or stroke (ischemic or hemorrhagic) - Age >75 years - Weight <60kg |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Policlinico G. Martino | Messina |
Lead Sponsor | Collaborator |
---|---|
University of Messina | Antonio Micari, Gianluca Di Bella, Natasha Irrera, Roberto Licordari |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between WNT/B-catenin levels and NTproBNP in patients presenting with acute myocardial infarction | NTproBNP as per center standard dosing | Measured at 5 days after PCI | |
Primary | Correlation between WNT/B-catenin levels and and left ventricular ejection fraction in patients presenting with acute myocardial infarction | Left ventricular ejection fraction will be measured with transthoracic Echocardiography at the specified timepoint | Measured at 5 days after PCI | |
Primary | Correlation between WNT/B-catenin levels and and extent of myocardial necrosis in patients presenting with acute myocardial infarction | Extent of myocardial necrosis will be measured with Carciac Magnetic Resonance Imaging at the specified timepoint | Measured at 5 days after PCI | |
Primary | Correlation between in hospital WNT/B-catenin levels and NTproBNP at follow-up in patients presenting with acute myocardial infarction | NTproBNP as per center standard dosing | Measured at 45 day after PCI | |
Primary | Correlation between in-hospital WNT/B-catenin levels and left ventricular ejection fraction at follow-up in patients presenting with acute myocardial infarction | Left ventricular ejection fraction will be measured with transthoracic Echocardiography at the specified timepoint | Measured at 45 day after PCI | |
Primary | Correlation between in-hospital WNT/B-catenin levels and extent of myocardial fibrosis at follow-up in patients presenting with acute myocardial infarction | Extent of myocardial fibrosis will be measured with Carciac Magnetic Resonance Imaging at the specified timepoint | Measured at 45 day after PCI | |
Secondary | Differences in WNT/B-catenin levels according to clinical presentation | Differences in results of activation of these molecular pathways in patients presenting with acute myocardial infarction and those selected in the control group by age, sex and risk factor matching | At baseline, 3, 5 and 45 day after PCI | |
Secondary | Differences in WNT/B-catenin levels in patients treated with ticagrelor or prasugrel | Differences in results of activation of these molecular pathways in patients treated with ticagrelor or prasugrel presenting with acute myocardial infarction | At baseline, 3, 5 and 45 day after PCI | |
Secondary | Differences in WNT/B-catenin levels in patients treated with or without Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors | Differences in results of activation of these molecular pathways in patients treated or not treated with Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors after acute myocardial infarction | At baseline, 3, 5 and 45 day after PCI |
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