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

NCT00384982 | Completed Phase 2 DMC

• 1 other identifier: Medical University of Vienna
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Bone marrow-derived stem cells; Acute myocardial infarction

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3-6 month

Secondary Outcomes (6)

• The feasibility of the bone marrow-derived stem cells delivery modes, determined by the rates of acute and subacute complications

  in-hospital

• Change in the left ventricular wall motion score index, measured by transthoracic echocardiography

  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

  3-6 month

• Change in left ventricular end-diastolic and end-systolic volumes by contrast ventriculography

  3-6 month

• Assessment of the clinical symptoms (CCS and NYHA) of the patients

  3, 6 and 12 month

Study Arms (1)

A, B, C, D

EXPERIMENTAL

Early or late; percutaneous intracoronary or combined (intramyocardial and intracoronary) administration of BM-MNCs

Procedure: Bone marrow-derived stem cells implantation

Interventions

Bone marrow-derived stem cells implantation PROCEDURE

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

A, B, C, D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Cardiology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Irene Lang, MD

  Department of Cardiology, Medical University of Vienna

  STUDY DIRECTOR

• Dietmar Glogar, MD

  Department of Cardiology, Medical University of Vienna

  STUDY CHAIR

• Mariann Gyongyosi, MD

  Department of Cardiology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2006
• First Posted: October 6, 2006
• Study Start: January 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 22, 2010

Record last verified: 2008-08

Locations

AU (1)