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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

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Bone marrow-derived stem cells implantation Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: A, B, C, D
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
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. The feasibility of the bone marrow-derived stem cells delivery modes, determined by the rates of acute and subacute complications [ Time Frame: in-hospital ]
  2. Change in the left ventricular wall motion score index, measured by transthoracic echocardiography [ Time Frame: 3-6 month ]
  3. 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 ]
  4. Change in left ventricular end-diastolic and end-systolic volumes by contrast ventriculography [ Time Frame: 3-6 month ]
  5. Assessment of the clinical symptoms (CCS and NYHA) of the patients [ Time Frame: 3, 6 and 12 month ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384982


Locations
Austria
Department of Cardiology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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

Responsible Party: Mariann Gyongyosi MD PhD FESC, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00384982     History of Changes
Other Study ID Numbers: Medical University of Vienna
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: August 2008

Keywords provided by Medical University of Vienna:
Bone marrow-derived stem cells
Acute myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases