RIGENERA 2.0 Trial

Summary

Study Objectives: 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

Timeline

Start

2020-01

Primary completion

2021-10

Completion

2021-12

Publications

• Leone AM, D'Amario D, Teofili L, Basile E, Cannata F, Graziani F, Marzilli M, Russo AM, Tarantini G, Ceconi C, Leone G, Trani C, Rebuzzi AG, Crea F. The combined effect of subcutaneous granulocyte- colony stimulating factor and myocardial contrast echocardiography with intravenous infusion of sulfur hexafluoride on post-infarction left ventricular function, the RIGENERA 2.0 trial: study protocol for a randomized controlled trial. Trials. 2016 Feb 19;17:97. doi: 10.1186/s13063-016-1172-0.

Drugs

Indications