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RIGENERA 2.0 Trial (RIGENERA)

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ClinicalTrials.gov Identifier: NCT02502747
Recruitment Status : Suspended (slow enrolment)
First Posted : July 20, 2015
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Maria Leone, MD, Catholic University of the Sacred Heart

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

Condition or disease Intervention/treatment Phase
Anterior Myocardial Infarction Heart Failure Drug: rhu G-CSF Drug: optimal standard of care Procedure: Myocardial Contrast Echocardiography Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Myocardial Contrast Echocardiography With Intravenous Infusion of Sulphur Hexafluoride on Post-infarction Left Ventricular Function"
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: G-CSF and Myocardial Contrast Echocardiography (MCE)
subcutaneous Granulocyte - Colony Stimulating Factor ( on top of optimal standard of care) and Myocardial Contrast Echocardiography with intravenous infusion of sulphur hexafluoride.
Drug: rhu G-CSF
rhu G-CSF will be administered 5 µg/kg twice daily for 5 days, subcutaneously
Other Name: recombinant human Granulocyte - Colony Stimulating Factor

Procedure: Myocardial Contrast Echocardiography
Myocardial Contrast Echocardiography with sulphur hexafluoride.

Active Comparator: Placebo and Myocardial Contrast Echocardiography (MCE)
Patients will be receive optimal standard of care and Myocardial Contrast Echocardiography with intravenous infusion of sulphur hexafluoride.
Drug: optimal standard of care
Optimal standard of care

Procedure: Myocardial Contrast Echocardiography
Myocardial Contrast Echocardiography with sulphur hexafluoride.




Primary Outcome Measures :
  1. Left ventricular ejection Fraction [ Time Frame: 6 months ]
    Left ventricular ejection fraction (LVEF) at 6 months assessed by Cardiac Magnetic Resonance and centrally reviewed


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Left ventricular ejection fraction (LVEF) [ Time Frame: 6 months ]
    Left ventricular ejection fraction (LVEF) assessed by 2D Echocardiography at 6 months and centrally reviewed

  4. 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

  5. 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

  6. MACCE [ Time Frame: 1 year ]
    Clinical Major adverse cardio-cerebrovascular events (death, myocardial infarction, stroke and rehospitalization due to heart failure) at 1 year


Other Outcome Measures:
  1. Incidence of adverse events [ Time Frame: 1 years ]
    adverse events

  2. Incidence of new neoplastic and hematological diseases [ Time Frame: 5 years ]
    neoplastic and hematological diseases



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Population Adult male or female patients aged < 80 years with acute myocardial infarction undergoing successful primary or rescue percutaneous recanalization of the infarct-related coronary artery, defined as TIMI 3 flow and residual stenosis <20%) within 24 hours of symptom onset and Left Ventricular Ejection Fraction (LVEF) ≤ 45% at 3-6 after revascularization, as documented by a two-dimensional echocardiogram.

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 <50% and TIMI flow ≥2) within 24 hours of symptom onset by successful percutaneous coronary intervention (PCI) or thrombolysis within 12 hours of symptom onset followed by successful PCI within 24 hours after thrombolysis
  5. Left ventricular ejection fraction ≤ 45% at 24 hours after revascularization, as documented by a two-dimensional echocardiogram.

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. GFR<30 ml/min
  8. Persistent fever or diarrhoea not responsive to treatment within 4 weeks prior screening or severe infection
  9. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
  10. Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502747


Locations
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Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, RM, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Antonio Maria Leone, MD, PhD Universita' Cattolica del Sacro Cuore
Study Chair: Filippo Crea, MD Universita' Cattolica del Sacro Cuore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antonio Maria Leone, MD, MD, PhD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02502747     History of Changes
Other Study ID Numbers: RIGENERA 2.0
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Anterior Wall Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Lenograstim
Sargramostim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs