|
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: |
NCT00501917 |
|
Date of registration:
|
13/07/2007 |
|
Primary sponsor: |
|
|
Public title:
|
MAGIC Cell-5-Combicytokine Trial
MAGIC Cell-5 |
|
Scientific title:
|
Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion –5-Combination Cytokine Therapy Trial |
|
Date of first enrolment:
|
March 2007 |
|
Target sample size:
|
116 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00501917 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Contacts
|
|
Name:
|
Hyo-Soo Kim, MD PhD |
|
Address:
|
|
|
Telephone:
|
82-2-2072-2226 |
|
Email:
|
hyosoo@snu.ac.kr |
|
Affiliation:
|
|
|
|
Name:
|
Hyo-Soo Kim, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Seoul National University Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- ST elevation acute myocardial infarction
- < 80years
- successful revascularization of culprit vessel
Exclusion Criteria:
- uncontrolled congestive heart failure
- uncontrolled myocardial ischemia
- uncontrolled ventricular arrhythmia
- malignancy
- serious hematologic disease
- chronic renal failure
Age minimum:
15 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Myocardial Infarction
|
|
Intervention(s)
|
|
Drug: G-CSF with/without darbepoetin, peripheral blood stem cell infusion
|
|
Primary Outcome(s)
|
|
change of left ventricular ejection fraction measured by cardiac MRI
[Time Frame: 6, 12, and 24month]
|
|
Secondary Outcome(s)
|
|
wall motion score index exercise capacity BNP
[Time Frame: 6,12, 24month]
|
|
Secondary ID(s)
|
|
MAGIC Cell-5
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|