Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT00756756
Status:
COMPLETED
Last Update Posted:
2008-09-22
First Post:
2008-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-19', 'studyFirstSubmitDate': '2008-09-19', 'studyFirstSubmitQcDate': '2008-09-19', 'lastUpdatePostDateStruct': {'date': '2008-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ejection fraction', 'timeFrame': '6 months'}, {'measure': 'Diastolic function(Tei index)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Drug complication', 'timeFrame': 'acute and 6 months'}, {'measure': 'Mortality', 'timeFrame': '6 months'}, {'measure': 'New revascularization and MACE', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['G-CSF', 'Myocardial infarction'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Ten patients in the treatment group and 10 patients in the control group were enrolled in this prospective, randomized, double blinded study. Two weeks after myocardial infarction that was accompanied by successful recanalization and stent implantation, the patients of the treatment group received 10 μg/kg body weight per day (divided BID) G-CSF subcutaneously for treatment duration of maximum 5.0 days. In both groups, ejection fraction was evaluated with echocardiography and cardiac scan (Gated SPECT method) 10 days after myocardial infarction and after 6 months. Tei index was measured by echocardiography.\n\nResults: No severe side effects of G-CSF treatment were observed. Ejection fraction determined by cardiac scan increased in the treatment group from 0.428 to 0.462 and from 0.470 to 0.496 in the control group but there was no significant improvement of left ventricular ejection fraction when the G-CSF treated group was compared to the controls (p=0.821 for cardiac scan and p=0.705 for echocardiography). Changes in Tei index was not significant in the treatment group (p=0.815) however it reached significant level in the control group (p=0.005), respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First anterior myocardial infarction.\n* Low systolic ventricular function.\n\nExclusion Criteria:\n\n* Bleeding tendency\n* Contraindication to G-CSF\n* Cardiogenic shock\n* Hemodynamic instability\n* Hepatic or renal disease\n* Multivessel disease'}, 'identificationModule': {'nctId': 'NCT00756756', 'briefTitle': 'The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study', 'orgStudyIdInfo': {'id': '86-3454'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'post MI post PCI and G-CSF infusion', 'interventionNames': ['Drug: G-CSF']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'post MI and post PCI only placebo infused', 'interventionNames': ['Drug: placebo infusion of normal saline']}], 'interventions': [{'name': 'G-CSF', 'type': 'DRUG', 'description': 'after 2 week post MI an d PCI G-CSF was infused for 5 days at dose of 10 microgram/Kg', 'armGroupLabels': ['1']}, {'name': 'placebo infusion of normal saline', 'type': 'DRUG', 'description': '2 week post MI and PCI normal saline was infused', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51318', 'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Shiraz University of Medical Sciences/Cardiology Ward/Namazi and Shahid Faghihi Hospital', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kojuri J M.D.', 'oldOrganization': 'Shiraz University of medical sciences'}}}}