Overview

This trial is active, not recruiting.

Conditions acute myocardial infarction, early left ventricular dysfunction
Treatments percutaneous coronary intervention, bmnc therapy
Phase phase 2
Sponsor Asklepios proresearch
Start date January 2009
End date January 2014
Trial size 40 participants
Trial identifier NCT00939042, 1777, 2008-004625-42

Summary

Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
PCI plus BNNC Therapy after acute myocardial infarction
bmnc therapy
Injection of BMNC after common PCI
(Active Comparator)
Percutaneous Coronary Intervention after acute myocardial infarction
percutaneous coronary intervention
common Percutaneous Coronary Intervention

Primary Outcomes

Measure
Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).
time frame: 12 months

Secondary Outcomes

Measure
Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.
time frame: 12 months
Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - LVDF < 45% after timely (max. 6 hours after the onset of symptomps) successful PCI - conventional therapy according to the ESC guidelines for heart failure - BMI > 20 and < 35 Exclusion Criteria: - PCI elder then 21 days - relevant valvular disease - history of stroke/multivessel disease/thromboembolic event etc. - DM Type I - pregancy

Additional Information

Official title Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells
Principal investigator Karl-Heinz Kuck, Prof. Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Asklepios proresearch.