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RIGENERA 2.0 Trial

NCT02502747 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-03-29

No results posted yet for this study

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

Interventions

DRUG

rhu G-CSF

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

DRUG

optimal standard of care

Optimal standard of care

PROCEDURE

Myocardial Contrast Echocardiography

Myocardial Contrast Echocardiography with sulphur hexafluoride.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Antonio Maria Leone, MD, PhD · Universita' Cattolica del Sacro Cuore

  • Filippo Crea, MD · Universita' Cattolica del Sacro Cuore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02502747 on ClinicalTrials.gov