Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-01 @ 11:08 AM
Study NCT ID:
NCT00882466
Status:
COMPLETED
Last Update Posted:
2009-04-17
First Post:
2009-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Erythropoietin at the Time of Reperfusion in Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-16', 'studyFirstSubmitDate': '2009-04-15', 'studyFirstSubmitQcDate': '2009-04-15', 'lastUpdatePostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creatinine kinase (CK), creatinine kinase-MB (CK-MB)', 'timeFrame': '4hr, 8hr, 12hr, 24hr, 48hr, 72hr'}], 'secondaryOutcomes': [{'measure': 'Infarct size assessed by cardiac MRI', 'timeFrame': 'day 4'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['erythropoietin'], 'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '20199815', 'type': 'DERIVED', 'citation': 'Suh JW, Chung WY, Kim YS, Kim KI, Jeon EJ, Cho YS, Youn TJ, Chae IH, Kim CH, Choi DJ. The effect of intravenous administration of erythropoietin on the infarct size in primary percutaneous coronary intervention. Int J Cardiol. 2011 Jun 2;149(2):216-220. doi: 10.1016/j.ijcard.2010.02.002. Epub 2010 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myocardial infarction \\<12hr\n* Age \\>18yrs\n* First myocardial infarction\n* culprit lesion : proximal to mid left anterior descending artery\n* Baseline coronary flow : TIMI Grade 0\\~1\n\nExclusion Criteria:\n\n* Patients with previous myocardial infarction\n* History of thrombotic complication\n* History of cerebral infarction\n* Uncontrolled hypertension\n* Increased hemoglobin level \\>17g/dL\n* Patients with mechanical valve\n* Cardiogenic shock'}, 'identificationModule': {'nctId': 'NCT00882466', 'briefTitle': 'The Effect of Erythropoietin at the Time of Reperfusion in Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'EPO in AMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'PCI only', 'description': 'primary PCI only'}, {'type': 'EXPERIMENTAL', 'label': 'EPO', 'interventionNames': ['Drug: human recombinant erythropoietin']}], 'interventions': [{'name': 'human recombinant erythropoietin', 'type': 'DRUG', 'description': 'intravenous bolus injection of EPO (50unit/kg)', 'armGroupLabels': ['EPO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'Dong-Ju Choi, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dong-Ju Choi', 'oldOrganization': 'Seoul National University Bundang Hospital'}}}}