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BONAMI (BOne Marrow in Acute Myocardial Infarction)

Primary Purpose

Acute and Severe Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Intracoronary injection of autologous bone marrow mononuclear cells
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute and Severe Myocardial Infarction focused on measuring Cell therapy, bone marrow mononuclear cells, myocardial infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men or women between 18-75 years. Acute myocardial infarction Absence of viability in the infarcted zone and LVEF <45%. Exclusion Criteria: History of prior myocardial infarction Significant stenosis in another coronary territory than the acutely treated vessel

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The treatment group

the control group

Arm Description

Intracoronary Injection of Autologous Bone Marrow Mononuclear C

Outcomes

Primary Outcome Measures

Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)

Secondary Outcome Measures

Left ventricle ejection fraction (LVEF) evaluated by radionuclide ventriculography, (3 and 12 months) and by echography (1, 3, 6, and 12 months). Segmental EF and myocardial viability evaluated by MRI (3 months)
Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection

Full Information

First Posted
September 13, 2005
Last Updated
April 29, 2014
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00200707
Brief Title
BONAMI (BOne Marrow in Acute Myocardial Infarction)
Official Title
Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.
Detailed Description
After successful percutaneous coronary intervention (PCI) for acute myocardial infarction, 100 patients are randomly assigned to either a control group (n=50) who receives an optimal medical treatment, or a bone-marrow-cell group (n=50) who receives an optimal medical treatment and intracoronary transfer of autologous bone-marrow cells 7•10 days after PCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute and Severe Myocardial Infarction
Keywords
Cell therapy, bone marrow mononuclear cells, myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The treatment group
Arm Type
Experimental
Arm Description
Intracoronary Injection of Autologous Bone Marrow Mononuclear C
Arm Title
the control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Intracoronary injection of autologous bone marrow mononuclear cells
Primary Outcome Measure Information:
Title
Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)
Time Frame
after 3 months and 1 year of treatment
Secondary Outcome Measure Information:
Title
Left ventricle ejection fraction (LVEF) evaluated by radionuclide ventriculography, (3 and 12 months) and by echography (1, 3, 6, and 12 months). Segmental EF and myocardial viability evaluated by MRI (3 months)
Time Frame
after 1,3,6 ,12 months of treatment
Title
Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women between 18-75 years. Acute myocardial infarction Absence of viability in the infarcted zone and LVEF <45%. Exclusion Criteria: History of prior myocardial infarction Significant stenosis in another coronary territory than the acutely treated vessel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia LEMARCHAND, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26666236
Citation
Manrique A, Lemarchand P, Delasalle B, Lairez O, Sportouch-Duckan C, Lamirault G, Le Corvoisier P, Neuder Y, Richardson M, Lebon A, Roncalli J, Piot C, Trochu JN, Teiger E, Hossein-Foucher C, Le Tourneau T. Predictors of ventricular remodelling in patients with reperfused acute myocardial infarction and left ventricular dysfunction candidates for bone marrow cell therapy: insights from the BONAMI trial. Eur J Nucl Med Mol Imaging. 2016 Apr;43(4):740-8. doi: 10.1007/s00259-015-3279-z. Epub 2015 Dec 15.
Results Reference
derived
PubMed Identifier
21127322
Citation
Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.
Results Reference
derived

Learn more about this trial

BONAMI (BOne Marrow in Acute Myocardial Infarction)

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