acute myocardial infarction MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent 2. Men and women of any ethnic origin aged = 18 years 3. Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI. 4. Successful acute reperfusion therapy (residual stenosis visually =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial within 30 days prior to randomisation 2. Pregnant or nursing women or women in childbearing age not able to esclude the possibility of a pregnancy 3. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol 4. Necessity to revascularise additional vessels, outside the target coronary artery after investigational therapy/placebo administration (additional revascularisations after primary PCI and before investigational therapy/placebo administration are allowed) 5. Persistent cardiogenic shock 6. Known hematologic and neoplastic diseases 7. Severe impaired renal function, i.e. GFR180 mmHg and diastolic >120 mmHg) 10. Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: nd;Timepoint(s) of evaluation of this end point: 6 months;Main Objective: To determine whether, in patients with large acute myocardial infarction undergoing primary or rescue angioplasty, the administration of subcutaneous Lenograstim [recombinant human Granulocyte-Colony Stimulating Factor (rhu G-CSF), Myelostim 34, Italfarmaco] associated with Myocardial Contrast Echocardiography and the intravenous infusion of sulphur hexafluoride (Sonovue, Bracco) determines an improvement: - in regional and global contractile function, myocardial perfusion and infarct size assessed by cardiovascular magnetic resonance- Echocardiographic parameters of LV function - in the serum profile of inflammatory and mobilizing cytokines and of biomarkers of myocardial damage and wall stress ;Primary end point(s): Endpoint secondari di efficacia: • Volume Telediastolico del ventricolo sinistro (LVEDV) documentato da Risonanza Magnetica Cardiaca a 6 mesi e rivalutata centralmente • Volume Telesistolico del ventricolo sinistro (LVEDV) documentato da Risonanza Magnetica Cardiaca a 6 mesi e rivalutata centralmente • Frazione di eiezione sinistra (LVEF) valutata tramite 2D Ecocardiografia a 6 mesi e rivalutata centralmente • Volume Telediastolico del ventricolo sinistro (LVEDV) valutato tramite 2D Ecocardiografia a 6 mesi e rivalutata centralmente • Volume Telesistolico del ventricolo sinistro (LVEDV) valutato tramite 2D Ecocardiografia a 6 mesi e rivalutata centralmente • Eventi Clinici cardio-cerebrovascolari maggiori (morte, infarto del miocardio, ictus e riospedalizzazione per scompenso cardiac) a 1 anno | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 6 months/1years | — |
Countries
Italy
Contacts
Public ContactDIPARTIMENTO SCIENZE CARDIOVASCOLAR
POLICLINICO GEMELLI
Outcome results
None listed