Back to resultsAutologous Stem Cell Transplantation in Acute Myocardial Infarction
Primary Purpose
Acute Anterior Wall Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Intracoronary aotologous stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Anterior Wall Myocardial Infarction focused on measuring Myocardial infarction, bone marrow cells, cell transplantation
Eligibility Criteria
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.
Sites / Locations
- Rikshospitalet-Radiumhospitalet HF
Outcomes
Primary Outcome Measures
whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00199823
First Posted
September 13, 2005
Last Updated
July 3, 2011
Sponsor
Oslo University Hospital
Collaborators
University of Oslo, Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00199823
Brief Title
Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Official Title
Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo, Ullevaal University Hospital
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Anterior Wall Myocardial Infarction
Keywords
Myocardial infarction, bone marrow cells, cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
Intracoronary aotologous stem cell transplantation
Primary Outcome Measure Information:
Title
whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
Secondary Outcome Measure Information:
Title
To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry
Title
To test whether mBMC treatment improve quality of life assessed by the SF 36 formula
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ketil Lunde, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rikshospitalet-Radiumhospitalet HF
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
16990383
Citation
Lunde K, Solheim S, Aakhus S, Arnesen H, Abdelnoor M, Egeland T, Endresen K, Ilebekk A, Mangschau A, Fjeld JG, Smith HJ, Taraldsrud E, Grogaard HK, Bjornerheim R, Brekke M, Muller C, Hopp E, Ragnarsson A, Brinchmann JE, Forfang K. Intracoronary injection of mononuclear bone marrow cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1199-209. doi: 10.1056/NEJMoa055706.
Results Reference
result
PubMed Identifier
22192151
Citation
Solheim S, Seljeflot I, Lunde K, Bratseth V, Aakhus S, Forfang K, Arnesen H. The influence of intracoronary injection of bone marrow cells on prothrombotic markers in patients with acute myocardial infarction. Thromb Res. 2012 Nov;130(5):765-8. doi: 10.1016/j.thromres.2011.11.045. Epub 2011 Dec 20.
Results Reference
derived
PubMed Identifier
21414223
Citation
Hopp E, Lunde K, Solheim S, Aakhus S, Arnesen H, Forfang K, Edvardsen T, Smith HJ. Regional myocardial function after intracoronary bone marrow cell injection in reperfused anterior wall infarction - a cardiovascular magnetic resonance tagging study. J Cardiovasc Magn Reson. 2011 Mar 17;13(1):22. doi: 10.1186/1532-429X-13-22.
Results Reference
derived
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Autologous Stem Cell Transplantation in Acute Myocardial Infarction
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