|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01395212 |
|
Date of registration:
|
14/07/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Stem Cell Therapy
MYSTAR-5-YEAR |
|
Scientific 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 |
|
Date of first enrolment:
|
July 2011 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01395212 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Case-Only, Time Perspective: Prospective
|
|
|
Countries of recruitment
|
|
Austria
| | | | | | | |
|
Contacts
|
|
Name:
|
Mariann Gyöngyösi, MD PhD FESC |
|
Address:
|
|
|
Telephone:
|
+43140400 |
|
Email:
|
mariann.gyongyosi@meduniwien.ac.at |
|
Affiliation:
|
|
|
|
Name:
|
Mariann Gyöngyösi, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Medical University of Vienna |
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Myocardial Infarction
|
|
Primary Outcome(s)
|
|
Occurrence of MACCE
[Time Frame: 5 years]
|
|
Secondary Outcome(s)
|
|
- Incidence of hospitalization due to angina pectoris or acute heart failure
[Time Frame: 5 years]
|
|
Breakpoint parameters of the primary endpoint MACCE
[Time Frame: 5 years]
|
|
Decrease in infarct size and stress-inducible myocardial ischemia measured by SPECT
[Time Frame: 5 years]
|
|
Incidence of implantation of implantable cardiac defibrillator (ICD) and/or pacemaker (PM)
[Time Frame: 5 years]
|
|
Increase in global LV EF, measured by cardiac MRI
[Time Frame: 5 years]
|
|
Occurrence of cardiac death
[Time Frame: 5 years]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|