NCT00501917

Brief Summary

Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

July 16, 2007

Status Verified

July 1, 2007

First QC Date

July 13, 2007

Last Update Submit

July 13, 2007

Conditions

Acute Myocardial Infarction

Keywords

acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • change of left ventricular ejection fraction measured by cardiac MRI

    6, 12, and 24month

Secondary Outcomes (1)

  • wall motion score index exercise capacity BNP

    6,12, 24month

Interventions

G-CSF with/without darbepoetin, peripheral blood stem cell infusionDRUG

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ST elevation acute myocardial infarction
  • \< 80years
  • successful revascularization of culprit vessel

You may not qualify if:

  • uncontrolled congestive heart failure
  • uncontrolled myocardial ischemia
  • uncontrolled ventricular arrhythmia
  • malignancy
  • serious hematologic disease
  • chronic renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Univesity Hospital

Seoul, South Korea

RECRUITING

Related Publications (2)

  • Kang HJ, Yoon EJ, Lee EJ, Kim MK, Suh JW, Park KW, Lee HY, Park KU, Cho YS, Koo BK, Chae IH, Choi DJ, Han KS, Kim HS, Park YB. Cotreatment with darbepoetin and granulocyte colony-stimulating factor is efficient to recruit proangiogenic cell populations in patients with acute myocardial infarction. Cell Transplant. 2012;21(5):1055-61. doi: 10.3727/096368911X627499. Epub 2012 Mar 22.

    PMID: 22449332DERIVED

  • Kang HJ, Kim MK, Kim MG, Choi DJ, Yoon JH, Park YB, Kim HS. A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'. Trials. 2011 Feb 7;12:33. doi: 10.1186/1745-6215-12-33.

    PMID: 21299845DERIVED

Study Officials

  • Hyo-Soo Kim, MD PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyo-Soo Kim, MD PhD

CONTACT

82-2-2072-2226hyosoo@snu.ac.kr

Hyun-Jae Kang, MD PhD

CONTACT

82-2-2072-2279nowkang@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Study Start

March 1, 2007

Study Completion

February 1, 2010

Last Updated

July 16, 2007

Record last verified: 2007-07

Locations

KR(1)