Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-29 @ 12:49 AM
Study NCT ID:
NCT00103350
Status:
COMPLETED
Last Update Posted:
2008-05-20
First Post:
2005-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of TG100-115 for Heart Attack Treated With Angioplasty
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': 'C539252', 'term': '3-(2,4-diamino-6-(3-hydroxyphenyl)pteridin-7-yl)phenol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-16', 'studyFirstSubmitDate': '2005-02-07', 'studyFirstSubmitQcDate': '2005-02-07', 'lastUpdatePostDateStruct': {'date': '2008-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and pharmacokinetics of TG100-115'}], 'secondaryOutcomes': [{'measure': 'Impact of TG100-115 on infarct size'}]}, 'conditionsModule': {'keywords': ['myocardial infarction', 'infarct size', 'angioplasty', 'percutaneous coronary intervention', 'Acute Myocardial Infarction'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis of this study is that TG100-115 can be given safely to patients who suffer a heart attack and undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces heart muscle damage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 yrs\n* ECG patterns consistent with an acute anterior myocardial infarction with ST segment elevation of 2mm in two contiguous ECG leads among leads V1-V4.\n* Have prolonged, continuous (lasting at least 20 mins) signs and symptoms of myocardial ischemia not eliminated with nitrates.\n* Intent to proceed to primary PCI within 6 hours of chest pain onset\n* Sign an informed consent form and be willing to attend follow-up visits for safety and other study assessments.\n\nExclusion Criteria:\n\n* Female of childbearing potential.\n* History of previous myocardial infarction.\n* History of congestive heart failure.\n* Requirement for a cardiac pacemaker or defibrillator.\n* Cardiogenic shock.\n* Patients previously treated with thrombolytic therapy.\n* Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease.'}, 'identificationModule': {'nctId': 'NCT00103350', 'briefTitle': 'Safety of TG100-115 for Heart Attack Treated With Angioplasty', 'nctIdAliases': ['NCT00104208'], 'organization': {'class': 'INDUSTRY', 'fullName': 'TargeGen'}, 'officialTitle': 'A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective Study to Evaluate the Safety and Potential Efficacy of Single, Increasing Doses of TG100-115 in Subjects Undergoing Percutaneous Coronary Intervention for Acute Anterior ST Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'TG001-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TG100-115', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'David Holmes, MD', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TargeGen', 'class': 'INDUSTRY'}}}}