Acute Myocardial Infarction
Conditions
Brief summary
Primary endpoint will be the infarct size, as assessed by cardiac MRI performed at 3-month follow-up, in the two arms. The adjudication of the primary outcome will be performed by a centralized, completely blinded analysis. Infarct size will be measured as percentage of left ventricular mass. Gadobutrol at the dose of 0.15 mmol/Kg will be used as contrast agent, with late gadolinium enhancement starting at 15 min onward. 5-SD will be utilized as method for quantification of infarct size.
Detailed description
Clinical secondary outcomes: Time to occurrence of the composite outcome measure including cardiovascular death, worsening HF during index hospitalization or post-discharge HF requiring repeat hospitalization within 3 months. Occurrence of re-MI, stroke or unplanned coronary revascularization at 3 months. All-cause death at 3 months. Duration of in-hospital stay for the index event. Difference in the change of body weight from randomization to 3-month follow-up. Arterial pressure values during h, Imaging secondary outcomes: Cardiac MRI, Transthoracic echocardiography, Laboratory secondary outcomes: B-type natriuretic peptide, Renal function, EPO, Red blood cell
Interventions
DRUGForxiga 10 mg film-coated tablets
Sponsors
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be the infarct size, as assessed by cardiac MRI performed at 3-month follow-up, in the two arms. The adjudication of the primary outcome will be performed by a centralized, completely blinded analysis. Infarct size will be measured as percentage of left ventricular mass. Gadobutrol at the dose of 0.15 mmol/Kg will be used as contrast agent, with late gadolinium enhancement starting at 15 min onward. 5-SD will be utilized as method for quantification of infarct size. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical secondary outcomes: Time to occurrence of the composite outcome measure including cardiovascular death, worsening HF during index hospitalization or post-discharge HF requiring repeat hospitalization within 3 months. Occurrence of re-MI, stroke or unplanned coronary revascularization at 3 months. All-cause death at 3 months. Duration of in-hospital stay for the index event. Difference in the change of body weight from randomization to 3-month follow-up. Arterial pressure values during h, Imaging secondary outcomes: Cardiac MRI, Transthoracic echocardiography, Laboratory secondary outcomes: B-type natriuretic peptide, Renal function, EPO, Red blood cell | — |
Countries
Italy
Outcome results
None listed