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Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study (MYSTAR)

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ClinicalTrials.gov Identifier: NCT00384982
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : January 22, 2010
Sponsor:
Information provided by:
Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE October 5, 2006
First Posted Date  ICMJE October 6, 2006
Last Update Posted Date January 22, 2010
Study Start Date  ICMJE January 2005
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2006)
  • Changes in resting myocardial perfusion defect size by gated SPECT scintigraphy 3 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy.
  • Changes in global left ventricular ejection fraction by gated SPECT scintigraphy 3 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy.
Change History Complete list of historical versions of study NCT00384982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2006)
  • The feasibility of the bone marrow-derived stem cells delivery modes, determined by the rates of acute and subacute complications
  • 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)
  • Change in the left ventricular wall motion score index, measured by transthoracic echocardiography
  • 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
  • Change in left ventricular end-diastolic and end-systolic volumes by contrast ventriculography
  • Assessment of the clinical symptoms (CCS and NYHA) of the patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study
Official Title  ICMJE Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: A Multicenter, Randomized Trial Comparing Early and Late Intracoronary or Combined (Intramyocardial and Intracoronary) Administration of Stem Cells
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE Procedure: Bone marrow-derived stem cells implantation
percutaneous BM-derived cell therapy
Other Names:
  • 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
Study Arms  ICMJE Experimental: A, B, C, D
Early or late; percutaneous intracoronary or combined (intramyocardial and intracoronary) administration of BM-MNCs
Intervention: Procedure: Bone marrow-derived stem cells implantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2008)
116
Original Enrollment  ICMJE
 (submitted: October 5, 2006)
360
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with a definitive AMI not earlier than 21 days and not later than 42 days before randomization (day 0 is the day of infarction)
  • Patients with open IRA without significant stenosis and TIMI flow 3, after successful percutaneous coronary intervention (PCI) of the IRA
  • Patients with two- or three-vessel disease might be included after adequate PCI if no significant coronary lesion can be seen in the non-infarct-related major vessels at the time of BM-SCs therapy
  • A persistent local new wall motion abnormality related to the recent infarct location.
  • Preserved myocardial viability, at least in the part of the recent infarction should be demonstrated by a preserved wall thickness and/or hypokinesia determined by transthoracic echocardiography or contrast ventriculography, and preserved tracer uptake determined by early and late resting Thallium myocardial scintigraphy or FDG-PET.
  • Global LVEF between 30 and 45%.
  • Written informed consent.

Exclusion Criteria:

  • Previous heart surgery
  • Small posterior or inferior AMI
  • Previous MI at the same location
  • Regional wall motion abnormality outside the area involved in the index AMI
  • Ventricular thrombus
  • Severe valvular heart disease
  • Severe renal, lung and liver disease
  • Disease of the hematopoetic system
  • Hemoglobin level below 9 mg%
  • The patient cannot follow the study protocol
  • NYHA functional class IV at baseline
  • Postinfarct angina
  • Significant coronary stenosis in the IRA requiring repeated PCI at the time of the planned BM-SCs therapy
  • Significant coronary lesion in one or more major coronary vessels, requiring revascularization
  • Age lower than 18 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00384982
Other Study ID Numbers  ICMJE Medical University of Vienna
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mariann Gyongyosi MD PhD FESC, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Irene Lang, MD Department of Cardiology, Medical University of Vienna
Study Chair: Dietmar Glogar, MD Department of Cardiology, Medical University of Vienna
Principal Investigator: Mariann Gyongyosi, MD Department of Cardiology, Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP