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

Autor: Mario Marzilli, Francesca Graziani, Domenico D'Amario, Antonio Giuseppe Rebuzzi, Francesco Cannata, Eloisa Basile, Filippo Crea, Claudio Ceconi, Antonio Maria Leone, Luciana Teofili, Giuseppe Tarantini, Carlo Trani, Giuseppe Leone, Antonio Matteo Russo
Rok vydání: 2015
Předmět:
0301 basic medicine
medicine.medical_treatment
Left
Myocardial Infarction
Medicine (miscellaneous)
Myocardial contrast echocardiography (MCE)
030204 cardiovascular system & hematology
Ventricular Function
Left
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
Clinical Protocols
law
Granulocyte Colony-Stimulating Factor
Ventricular Function
Pharmacology (medical)
Myocardial infarction
Infusions
Intravenous
Bone marrow-derived stem cells
ST-elevation myocardial infarction (STEMI)
Granulocyte-colony stimulating factor (G-CSF)
Remodeling
Post-myocardial infarction heart failure
Ejection fraction
Cardiogenic shock
Echocardiography
Cardiology
cardiovascular system
Intravenous
medicine.medical_specialty
Infusions
Sulfur Hexafluoride
Revascularization
03 medical and health sciences
Internal medicine
Humans
Length of Stay
medicine
cardiovascular diseases
Intensive care medicine
business.industry
Ambientale
medicine.disease
Clinical trial
030104 developmental biology
Heart failure
Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE
business
Mace
Zdroj: Trials
ISSN: 1745-6215
0250-2747
Popis: Background Several clinical trials and recent meta-analyses have demonstrated that administration of recombinant human granulocyte-colony stimulating factor (G-CSF) is safe and, only in patients with large acute myocardial infarction (AMI), is associated with an improvement in left ventricular ejection fraction. Moreover, the mobilization and engraftment of the bone marrow-derived cells may differ significantly among patients, interfering with the restoration of left ventricular function after treatment. Therefore, the clinical potential application of the G-CSF has not yet been fully elucidated. Methods/Design The RIGENERA 2.0 trial is a multicenter, phase II, placebo-controlled, randomized, open-label, with blinded evaluation of endpoints (PROBE) trial in which 120 patients with an acute ST-elevation myocardial infarction (STEMI) undergoing successful revascularization but with residual myocardial dysfunction will be enrolled. In cases where there is a left ventricular ejection fraction (LVEF) ≤45 % the patient will be electronically randomized (1:1 ratio) to receive either subcutaneous recombinant human G-CSF (group 1) or placebo (group 2) both added on top of optimal standard of care. Both groups will undergo myocardial contrast echocardiography with intravenous infusion of sulfur hexafluoride (MCE) whilst undergoing the echocardiogram. The primary efficacy endpoint is the evaluation of the LVEF at 6 months after AMI assessed by cardiac magnetic resonance. Secondary efficacy endpoints are the evaluation of LVEF at 6 months after AMI assessed by echocardiography, left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) assessed by cardiac magnetic resonance and echocardiography at 6 months, together with the incidence of major adverse clinical events (MACE) defined as death, myocardial infarction, sustained cardiac arrhythmias, cardiogenic shock, stroke and re-hospitalization due to heart failure at 1 year. Discussion The RIGENERA 2.0 trial will test whether G-CSF administration and MCE, through the enhancement of the bone marrow-derived cells homing in the myocardium, determines an improvement in regional and global contractile function, myocardial perfusion and infarct extension in patients with large AMI. The results of the present study are expected to envision routine clinical use of this safe, affordable and reproducible approach in patients with successful revascularization after AMI. Trial registration ClinicalTrials.gov: NCT02502747 (29 June 2015); EudraCT: 2015-002189-21 (10 July 2015). Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1172-0) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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