Clinical trial NCT00199823: Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Official title: Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Anterior Wall Myocardial Infarction
Keywords: Myocardial infarction
bone marrow cells
cell transplantation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Ullevaal University Hospital
First posted: 2005-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
Secondary outcomes:
measure: To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry
measure: To test whether mBMC treatment improve quality of life assessed by the SF 36 formula
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet HF
Study officials:
affiliation: Oslo University Hospital
name: Ketil Lunde, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.