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Sponsors and Collaborators: |
Rikshospitalet-Radiumhospitalet HF University of Oslo Ullevaal University Hospital |
Information provided by: | Rikshospitalet-Radiumhospitalet HF |
ClinicalTrials.gov Identifier: | NCT00199823 |
Objectives
Intracoronary transplantation of different cell populations have been used in acute myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI.
Design
The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days after PCI or to control. Left ventricular function, exercise capacity, biochemical status, functional class, quality of life and complications are validated at baseline and during a 12-month follow up.
Condition | Intervention | Phase |
Acute Anterior Wall Myocardial Infarction |
Gene Transfer: Intracoronary aotologous stem cell transplantation |
Phase II |
MedlinePlus related topics: | Exercise and Physical Fitness Heart Attack |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Autologous Stem Cell Transplantation in Acute Myocardial Infarction |
Estimated Enrollment: | 100 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | May 2006 |
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Norway | |||||
Rikshospitalet-Radiumhospitalet HF | |||||
Oslo, Norway, 0027 |
Rikshospitalet-Radiumhospitalet HF |
University of Oslo |
Ullevaal University Hospital |
Principal Investigator: | Ketil Lunde, MD | Rikshospitalet-Radiumhospitalet HF |
Study ID Numbers: | S-03115 |
First Received: | September 13, 2005 |
Last Updated: | November 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00199823 |
Health Authority: | Norway: Norwegian Medicines Agency; Norway: The Data Inspectorate |
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