Clinical trial NCT01395212: MYSTAR-5-YEAR: Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Cell Therapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Cell-based cardiac regenerative therapy
Intramyocardial injections
NOGA procedure
Acute myocardial infarction
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients included into the MYSTAR randomized study

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.

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

Primary outcomes:
measure: Occurrence of MACCE
timeFrame: 5 years
Secondary outcomes:
measure: Clinical symptoms (CCS, NYHA)
timeFrame: 5 years
measure: Changes in global EF
timeFrame: 5 years
measure: Size of infarction
timeFrame: 5 years
measure: Left ventricular end-diastolic and end-systolic volumes
timeFrame: 5 years
measure: Right ventricular end-diastolic and end-systolic volumes
timeFrame: 5 years
measure: Right ventricular cardiac output
timeFrame: 5 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Mariann Gyöngyösi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.