NCT00756756

Brief Summary

The investigators applied G-CSF to patients 2 weeks after acute anterior MI and successful PCI to evaluate the efficacy and safety of G-CSF in improving myocardial function as cytokine which improve inflammation and mobilize stem cells from bone marrow for regeneration of myocardium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
Last Updated

September 22, 2008

Status Verified

September 1, 2008

Enrollment Period

4 months

First QC Date

September 19, 2008

Last Update Submit

September 19, 2008

Conditions

Myocardial Infarction

Keywords

G-CSFMyocardial infarction

Outcome Measures

Primary Outcomes (2)

  • Ejection fraction

    6 months

  • Diastolic function(Tei index)

    6 months

Secondary Outcomes (3)

  • Drug complication

    acute and 6 months

  • Mortality

    6 months

  • New revascularization and MACE

    6 months

Study Arms (2)

1

EXPERIMENTAL

post MI post PCI and G-CSF infusion

Drug: G-CSF

2

PLACEBO COMPARATOR

post MI and post PCI only placebo infused

Drug: placebo infusion of normal saline

Interventions

G-CSFDRUG

after 2 week post MI an d PCI G-CSF was infused for 5 days at dose of 10 microgram/Kg

1
placebo infusion of normal salineDRUG

2 week post MI and PCI normal saline was infused

2

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First anterior myocardial infarction.
  • Low systolic ventricular function.

You may not qualify if:

  • Bleeding tendency
  • Contraindication to G-CSF
  • Cardiogenic shock
  • Hemodynamic instability
  • Hepatic or renal disease
  • Multivessel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences/Cardiology Ward/Namazi and Shahid Faghihi Hospital

Shiraz, Fars, 51318, Iran

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

June 1, 2007

Primary Completion

October 1, 2007

Study Completion

February 1, 2008

Last Updated

September 22, 2008

Record last verified: 2008-09

Locations

IR(1)