MYSTAR-5-YEAR: Long-term Follow-up of Patients With Ische... | NCT01395212

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

NCT01395212

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Oct 29, 2013Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

May 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jul 14, 2011

First Submission Date that Met QC Criteria

Jul 14, 2011

First Posted Date

Jul 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2013

Last Update Posted Date

Oct 29, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mariann Gyongyosi, Prof. Dr., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Label	Type	Description	Intervention Names
Cardiac stem cell therapy 5 years ago

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of MACCE	MACCE is defined as major adverse cardiac and cerebrovascular events including re-AMI, TVR, all-cause death and stroke at the 5-year FUP of the patients enrolled into the MYSTAR study and underwent cardiac stem cell therapy.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Clinical symptoms (CCS, NYHA)		5 years
Changes in global EF		5 years
Size of infarction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients included into the MYSTAR randomized study

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mariann Gyöngyösi, MD PhD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		A-1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27764157	Derived	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.