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Completed

NCT Number: NCT00200707

BONAMI (BOne Marrow in Acute Myocardial Infarction)

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nantes University Hospital

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracoronary injection of autologous bone marrow mononuclear cells

Procedure

Primary outcomes

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

    Time frame: after 3 months and 1 year of treatment

Secondary outcomes

  1. 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

  2. Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Apr 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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