Autologous Stem Cell Transplantation in Acute Myocardial Infarction

Acute Anterior Wall Myocardial Infarction Clinical Trial

Official title:

Autologous Stem Cell Transplantation in Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199823
• Other study ID #: S-03115
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: July 3, 2011
• Start date: September 2003
• Est. completion date: May 2006

Study information

• Verified date: September 2010
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: The Data Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Anterior Wall Myocardial Infarction
• Anterior Wall Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Genetic:
• Intracoronary aotologous stem cell transplantation

Locations

Country	Name	City	State
Norway	Rikshospitalet-Radiumhospitalet HF	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Ullevaal University Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Lunde K, Solheim S, Aakhus S, Arnesen H, Abdelnoor M, Egeland T, Endresen K, Ilebekk A, Mangschau A, Fjeld JG, Smith HJ, Taraldsrud E, Grøgaard HK, Bjørnerheim R, Brekke M, Müller C, Hopp E, Ragnarsson A, Brinchmann JE, Forfang K. Intracoronary injection — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
Secondary	To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry
Secondary	To test whether mBMC treatment improve quality of life assessed by the SF 36 formula