Autologous Stem Cell Transplantation in Acute Myocardial Infarction - Full Text View

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	Gene Transfer: Intracoronary aotologous stem cell transplantation	Phase II

MedlinePlus related topics:

Exercise and Physical Fitness Heart Attack

U.S. FDA Resources

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

Further study details as provided by Rikshospitalet-Radiumhospitalet HF:

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

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199823

Locations


Norway
	Rikshospitalet-Radiumhospitalet HF
	Oslo, Norway, 0027

Sponsors and Collaborators

Rikshospitalet-Radiumhospitalet HF

University of Oslo

Ullevaal University Hospital

Investigators


Principal Investigator:	Ketil Lunde, MD	Rikshospitalet-Radiumhospitalet HF

More Information

Publications of Results:

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.

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

Keywords provided by Rikshospitalet-Radiumhospitalet HF:

Myocardial infarction

bone marrow cells

cell transplantation

Study placed in the following topic categories:

Necrosis

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Ischemia

Infarction

Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 21, 2008

Sponsors and Collaborators:	Rikshospitalet-Radiumhospitalet HF University of Oslo Ullevaal University Hospital
Information provided by:	Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier:	NCT00199823