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Autologous Stem Cell Transplantation in Acute Myocardial Infarction

Phase 2
Completed
Conditions
Acute Anterior Wall Myocardial Infarction
Registration Number
NCT00199823
Lead Sponsor
Oslo University Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (1)

Rikshospitalet-Radiumhospitalet HF

🇳🇴

Oslo, Norway

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