RIGENERA 2.0 Trial

NCT02502747 | Withdrawn Phase 2 DMC

• 1 other identifier: RIGENERA 2.0
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Anterior Myocardial Infarction; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection Fraction

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

  6 months

Secondary Outcomes (6)

• Left ventricular end-diastolic volume (LVEDV)

  6 months

• Left ventricular end-systolic volume (LVEDV)

  6 months

• Left ventricular ejection fraction (LVEF)

  6 months

• Left ventricular end-diastolic volume (LVEDV)

  6 months

• Left ventricular end-systolic volume (LVESV)

  6 months

Other Outcomes (2)

• Incidence of adverse events

  1 years

• Incidence of new neoplastic and hematological diseases

  5 years

Study Arms (2)

G-CSF and Myocardial Contrast Echocardiography (MCE)

EXPERIMENTAL

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; Procedure: Myocardial Contrast Echocardiography

Placebo and Myocardial Contrast Echocardiography (MCE)

ACTIVE COMPARATOR

Patients will be receive optimal standard of care and Myocardial Contrast Echocardiography with intravenous infusion of sulphur hexafluoride.

Drug: optimal standard of care; Procedure: Myocardial Contrast Echocardiography

Interventions

rhu G-CSF DRUG

rhu G-CSF will be administered 5 µg/kg twice daily for 5 days, subcutaneously

Also known as: recombinant human Granulocyte - Colony Stimulating Factor

G-CSF and Myocardial Contrast Echocardiography (MCE)

optimal standard of care DRUG

Optimal standard of care

Placebo and Myocardial Contrast Echocardiography (MCE)

Myocardial Contrast Echocardiography PROCEDURE

Myocardial Contrast Echocardiography with sulphur hexafluoride.

G-CSF and Myocardial Contrast Echocardiography (MCE); Placebo and Myocardial Contrast Echocardiography (MCE)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent
• Men and women of any ethnic origin aged ≥ 18 years
• Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI.
• 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
• Left ventricular ejection fraction ≤ 45% at 24 hours after revascularization, as documented by a two-dimensional echocardiogram.

You may not qualify if:

• Participation in another clinical trial within 30 days prior to randomisation
• Pregnant or nursing women or women in childbearing age not able to esclude the possibility of a pregnancy
• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
• 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)
• Persistent cardiogenic shock
• Known hematologic and neoplastic diseases
• Severe impaired renal function, i.e. GFR\<30 ml/min
• Persistent fever or diarrhoea not responsive to treatment within 4 weeks prior screening or severe infection
• Uncontrolled hypertension (systolic \>180 mmHg and diastolic \>120 mmHg)
• Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, RM, 00168, Italy

Location

Related Publications (1)

• 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.

  PMID: 26891753 DERIVED

MeSH Terms

Conditions

Anterior Wall Myocardial Infarction; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Antonio Maria Leone, MD, PhD

  Universita' Cattolica del Sacro Cuore

  PRINCIPAL INVESTIGATOR

• Filippo Crea, MD

  Universita' Cattolica del Sacro Cuore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 20, 2015
• Study Start: January 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

IT (1)