BONAMI (BOne Marrow in Acute Myocardial Infarction) - Full Text View

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00200707

Purpose

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.

Condition	Intervention	Phase
Acute and Severe Myocardial Infarction	Procedure: Intracoronary injection of autologous bone marrow mononuclear cells	Phase II

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction

Further study details as provided by Nantes University Hospital:

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

Estimated Enrollment:	100
Study Start Date:	December 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200707

Contacts

Contact: Patricia LEMARCHAND, MD	00 +33 2 40 41 29 91	patricia.lemarchand@chu-nantes.fr
Contact: Patricia LEMARCHAND, MD	00 + 33 2 40 41 29 91	patricia.lemarchand@chu-nantes.fr

Locations

France
Nantes University Hospital	Recruiting
Nantes, France, 44093
Contact: Patricia LEMARCHAND, MD 00 +33 2 40 41 29 91 patricia.lemarchand@chu-nantes.fr
Principal Investigator: Patricia LEMARCHAND, MD

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Patricia LEMARCHAND, MD

Nantes University Hospital

More Information

No publications provided

Study ID Numbers:	BRD/03/2-B
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00200707 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:

- Cell therapy
- bone marrow mononuclear cells
- myocardial infarction

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009