Clinical Trial: RIGENERA 2.0 Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional




Official Title: RIGENERA 2.0 (Recupero Dall'Infarto Miocardico Con G-CSF E Nuovi Esempi di Rigenerazione Avanzata) Project: "The Combined Effect of Subcutaneous Granulocyte - Colony Stimulating Factor and Myocar

Brief 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

Detailed Summary:

  1. INTRODUCTION 1.1. BACKGROUND AND RATIONALE OF THE STUDY The long term prognosis of patients suffering from acute myocardial infarction (AMI) has progressively improved since the introduction of reperfusion therapies and in particular primary angioplasty [1]. In the setting of ST-elevation myocardial infarction (STEMI), the immediate reopening of acutely occluded coronary arteries via primary angioplasty is the treatment of choice to salvage ischemic myocardium. However, the sudden re-initiation of blood flow can lead to a local acute inflammatory response with further endothelial and myocardial damage. This phenomenon, described as 'reperfusion injury', may explain why, despite optimum myocardial reperfusion, the short-term mortality after AMI approaches 7% [1] and the incidence of heart failure approaches 15-20% [2][3]. Despite the use of full conventional treatment, including ACE inhibitors, beta-blockers, aldosterone inhibitors and diuretics, in the context of randomised controlled trials yearly mortality rates of patients with post-infarction heart failure are still in the range of 10-13% and rehospitalisation for worsening of heart failure occurs at a yearly rate of 6-8 % [4]. Registry data indicate a more dismal outcome in real world clinical experience. A major reason for the high morbidity and mortality is that the heart has an inadequate regenerative response to the myocardial necrosis sustained following AMI; cell death from the ischemic damage can lead to progressive ventricular dilation and dysfunction through the processes of adverse left ventricular remodelling. However, the discovery of tissue resident cardiac stem cells in the mammalian heart [5] has challenged the long held belief that the heart is a terminally-differentiated organ and opens up the possibility of using bone marrow derived stem cells to repair the heart. Indeed
    Sponsor: Catholic University of the Sacred Heart




    Current Primary Outcome: Left ventricular ejection Fraction [ Time Frame: 6 months ]

    Left ventricular ejection fraction (LVEF) at 6 months assessed by Cardiac Magnetic Resonance and centrally reviewed


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Left ventricular end-diastolic volume (LVEDV) [ Time Frame: 6 months ]
      Left ventricular end-diastolic volume (LVEDV) assessed by Cardiac Magnetic Resonance at 6 months and centrally reviewed
    • Left ventricular end-systolic volume (LVEDV) [ Time Frame: 6 months ]
      Left ventricular end-systolic volume (LVEDV) assessed by Cardiac Magnetic Resonance at 6 months and centrally reviewed
    • Left ventricular ejection fraction (LVEF) [ Time Frame: 6 months ]
      Left ventricular ejection fraction (LVEF) assessed by 2D Echocardiography at 6 months and centrally reviewed
    • Left ventricular end-diastolic volume (LVEDV) [ Time Frame: 6 months ]
      Left ventricular end-diastolic volume (LVEDV) assessed by 2D Echocardiography at 6 months and centrally reviewed
    • Left ventricular end-systolic volume (LVESV) [ Time Frame: 6 months ]
      Left ventricular end-systolic volume (LVEDV) assessed by 2D Echocardiography at 6 months and centrally reviewed
    • MACCE [ Time Frame: 1 year ]
      Clinical Major adverse cardio-cerebrovascular events (death, myocardial infarction, stroke and rehospitalization due to heart failure) at 1 year


    Original Secondary Outcome: Same as current

    Information By: Catholic University of the Sacred Heart




    Dates:
    Date Received: June 29, 2015
    Date Started: January 2016
    Date Completion: December 2017
    Last Updated: February 9, 2017
    Last Verified: February 2017