Autologous Stem Cell Transplantation in Acute Myocardial Infarction
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
Genetic: Intracoronary aotologous stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Autologous Stem Cell Transplantation in Acute Myocardial Infarction |
- whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
- To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry
- To test whether mBMC treatment improve quality of life assessed by the SF 36 formula
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- age 40-75 years
- anterior wall AMI with 120-720 minutes from onset of symptoms to PCI
- ST elevation on ECG according to WHO criteria
- angiographically significant stenosis on LAD proximal to the second diagonal branch
- successful PCI with stenting of culprit lesion
- hypokinetic, akinetic or dyskinetic segments assessed by echocardiography in a standard 16 segment model and
- CK-MB above 3 times upper reference value.
Exclusion criteria:
- previous MI with established significant Q-waves on ECG
- cardiogenic shock
- permanent pacemaker or other contraindication to MRI
- stroke with significant sequela
- short life expectancy due to extra cardiac reason
- uncontrolled endocrinological disturbance
- HIV and/or HBV/HCV positive serology
- mental disorder or other condition which interferes with patient possibility to comply with the protocol.
Contacts and Locations| Norway | |
| Rikshospitalet-Radiumhospitalet HF | |
| Oslo, Norway, 0027 | |
| Principal Investigator: | Ketil Lunde, MD | Oslo University Hospital |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00199823 History of Changes |
| Other Study ID Numbers: | S-03115 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 3, 2011 |
| Health Authority: | Norway: Norwegian Medicines Agency Norway: The Data Inspectorate |
Keywords provided by Oslo University Hospital:
|
Myocardial infarction bone marrow cells cell transplantation |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Anterior Wall Myocardial Infarction Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013