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MYSTAR-5-YEAR: Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Cell Therapy

NCT ID: NCT01395212

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-06-30

Brief Summary

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The MYSTAR-5-YEAR study controls the patients 5 years after treatment with combined (intramyocardial and intracoronary) delivery of autologous BM-MNCs.

The clinical endpoint of this prospective non-randomized observational study is the MACCE, defined as major adverse cardiac and cerebrovascular events. Patients will be investigated by echocardiography, SPECT and MRI. 2D (NOGA-guided SPECT) and 3D (NOGA-guided MRI) imaging will refine the evaluation with more exact analysis of the intramyocardial injected areas (ROI).

Detailed Description

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Background: Based on the available long-term results of cardiac stem cell therapies, it seems, that it offers short-term moderate benefits, but the long-term outcome is still matter of debate. In 2008, the Austrian arm of the MYSTAR study (a prospective multi-center single-blind trial) including patients with recent AMI and treated with combined (intramyocardial and intracoronary) delivery of autologous BM-MNCs has been completed with 1-year FUP. The MYSTAR results showed moderate but significant improvement in infarct size and LV function similar to other trials, and confirmed safety, feasibility and efficacy of BMC treatment in AMI patients. The patients enrolled in the study reach the 5 to 8 years FUP at 2011, raising the question whether the combined delivery of autologous BM-MNCs results in a long-term benefit for these patients.

Aim of the study: To investigate the long-term, 5 years clinical outcome of patients enrolled into the MYSTAR study.

Study design: Prospective non-randomized single-center Austrian long-term FUP registry.

Study patients: A total of 60 patients with previous cardiac stem cell therapy (participated in the MYSTAR study) will be included in the present study

Primary endpoint: occurrence of MACCE (major adverse cardiac and cerebrovascular events, including all-cause death, re-AMI, revascularization and stroke) during the mean 5 years follow-up.

Secondary endpoints: improvements of clinical symptoms, expressed as CCS and NYHA scores, change in global LV EF, measured by echocardiography, size of infarction determined by stress-rest SPECT, LV and RV volumes, function and cardiac output measured by cardiac MRI.

Conditions

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Acute Myocardial Infarction

Keywords

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Cell-based cardiac regenerative therapy Intramyocardial injections NOGA procedure Acute myocardial infarction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac stem cell therapy 5 years ago

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Previous participation in the MYSTAR study, inclusion either in the Early or Late groups
* Signed informed consent

Exclusion Criteria

* Non-willingness of participation in the present FUP study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Mariann Gyongyosi

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariann Gyöngyösi, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Gyongyosi M, Giurgea GA, Syeda B, Charwat S, Marzluf B, Mascherbauer J, Jakab A, Zimba A, Sarkozy M, Pavo N, Sochor H, Graf S, Lang I, Maurer G, Bergler-Klein J; MYSTAR investigators. Long-Term Outcome of Combined (Percutaneous Intramyocardial and Intracoronary) Application of Autologous Bone Marrow Mononuclear Cells Post Myocardial Infarction: The 5-Year MYSTAR Study. PLoS One. 2016 Oct 20;11(10):e0164908. doi: 10.1371/journal.pone.0164908. eCollection 2016.

Reference Type DERIVED
PMID: 27764157 (View on PubMed)

Other Identifiers

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MUW

Identifier Type: -

Identifier Source: org_study_id