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

Acute Myocardial Infarction Clinical Trial

— MYSTAR-5-YEAR  

Official title:

Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Combined Delivery of Autologous Bone-marrow Mononuclear Cells: 5-year Clinical Outcome of the MYSTAR Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395212
• Other study ID #: MUW
• Status: Completed
• Phase: N/A
• First received: July 14, 2011
• Last updated: October 26, 2013
• Start date: July 2011
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Artery Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Clinical symptoms (CCS, NYHA)		5 years	No
Secondary	Changes in global EF		5 years	No
Secondary	Size of infarction		5 years	No
Secondary	Left ventricular end-diastolic and end-systolic volumes		5 years	No
Secondary	Right ventricular end-diastolic and end-systolic volumes		5 years	No
Secondary	Right ventricular cardiac output		5 years	No