A Phase 2 interventional study of Bone marrow-derived stem cells implantation in Myocardial Infarction, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-22.
Sponsored by Medical University of Vienna · Phase 2, Interventional, and Treatment
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of bone marrow-derived stem cells to patients after acute myocardial infarction with reopened infarct-related artery.
Previous data suggest that bone marrow-derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling.
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery.
The primary endpoints are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated SPECT scintigraphy) 3 months after BM-SCs therapy.
The secondary endpoints relate to evaluation of 1) the safety and feasibility of the application modes, 2) the changes in left ventricular wall motion score index (transthoracic echocardiography), 3) myocardial voltage and segmental wall motion (NOGA mapping), 4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and 5) the clinical symptoms (CCS and NYHA) at follow-up.
Patients are randomly assigned into one of four groups, Group A: early treatment (21-42 days after AMI) with intracoronary injection; Group B: early treatment (21-42 days after AMI) with combined (intramyocardial and intracoronary) application; Group C: late treatment (3 months after AMI) with intracoronary delivery; and Group D: late treatment (3 months after AMI) with combined (intramyocardial and intracoronary) administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients.
The MYSTAR trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 116 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Early or late; percutaneous intracoronary or combined (intramyocardial and intracoronary) administration of BM-MNCs
Procedure: Bone marrow-derived stem cells implantation
percutaneous BM-derived cell therapy
Also known as: early intracoronary delivery of BM-MNCs, late intracoronary delivery of BM-MNCs, early combined (intramyoc+intracor) delivery of BM-MNCs, late combined (intramyoc+intracor) delivery of BM-MNCs
Changes in resting myocardial perfusion defect size by gated SPECT scintigraphy 3-6 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy.
Time frame: 3-6 month
Changes in global left ventricular ejection fraction by gated SPECT scintigraphy 3-6 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy.
Time frame: 3-6 month
The feasibility of the bone marrow-derived stem cells delivery modes, determined by the rates of acute and subacute complications
Time frame: in-hospital
Change in the left ventricular wall motion score index, measured by transthoracic echocardiography
Time frame: 3-6 month
Change in the myocardial voltage as a parameter of myocardial viability obtained by NOGA endocardial mapping, with segmental wall motion expressed by local linear shortening on NOGA mapping
Time frame: 3-6 month
Change in left ventricular end-diastolic and end-systolic volumes by contrast ventriculography
Time frame: 3-6 month
Assessment of the clinical symptoms (CCS and NYHA) of the patients
Time frame: 3, 6 and 12 month
The safety of the bone marrow-derived stem cells delivery modes, expressed as the rates of long-term major adverse cardiac events (MACE: death, target vessel revascularization and non-fatal AMI)
Time frame: 3, 6 and 12 month
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna