- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01395212
MYSTAR-5-YEAR: Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Cell Therapy (MYSTAR-5-YEAR)
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
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).
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Vienna, Østerrike, A-1090
- Medical University of Vienna
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Cardiac stem cell therapy 5 years ago
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Occurrence of MACCE
Tidsramme: 5 years
|
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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Clinical symptoms (CCS, NYHA)
Tidsramme: 5 years
|
5 years
|
Changes in global EF
Tidsramme: 5 years
|
5 years
|
Size of infarction
Tidsramme: 5 years
|
5 years
|
Left ventricular end-diastolic and end-systolic volumes
Tidsramme: 5 years
|
5 years
|
Right ventricular end-diastolic and end-systolic volumes
Tidsramme: 5 years
|
5 years
|
Right ventricular cardiac output
Tidsramme: 5 years
|
5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mariann Gyöngyösi, MD PhD, Medical University of Vienna
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MUW
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