Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-29 @ 5:22 PM
Study NCT ID:
NCT01018706
Status:
COMPLETED
Last Update Posted:
2013-12-17
First Post:
2009-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goodness of Clinical History During Stemi PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-16', 'studyFirstSubmitDate': '2009-11-24', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequacy of medical history collection at the moment of primary pci and 4 days after the index procedure', 'timeFrame': 'Adequacy of medical history collection at the moment of primary pci and 4 days after the index procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary pci', 'Stent', 'Medical Hystory', 'Antiplatelet therapy', 'Compliance'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm or confute the hypothesis that in patients treated with primary pci is not always possible to collect an adequate medical history, the investigators created a clinical registry in which the investigators collect current or previous medical history relevant to DES utilization , in two distinct times.', 'detailedDescription': "GHOST Registry\n\nUse of drug-eluting stent (DES) in STEMI is sometimes limited, by the concern that adequate information, relating to the current or previous medical history, can not be obtained due to the patient's critical condition. A less than adequate medical history would expose patients treated with DES to a particular risk in case that an absolute or relative contraindication to the required long-term double antiplatelet therapy is not fully elucidated before DES implantation.\n\nTo confirm or confute the hypothesis that in patients treated with primary pci is not always possible to collect an adequate medical history, we created a clinical registry in which we collect current or previous medical history relevant to DES utilization , in two distinct times:\n\nTime zero in which the medical history collection is taken in the cath-lab during the primary pci\n\nTime one in which the second medical history collection is taken 4 days after the index procedure when the patient clinical conditions no longer impede an adequate medical history collection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Four hundred patients with STEMI treated with primary PCI or rescue PCI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients presenting with STEMI treated with primary or rescue PCI\n\nExclusion Criteria:\n\n* Patient in cardiogenic shock and all those patients unable to communicate with the doctors at the moment of medical history taking'}, 'identificationModule': {'nctId': 'NCT01018706', 'acronym': 'GHOST', 'briefTitle': 'Goodness of Clinical History During Stemi PCI', 'organization': {'class': 'OTHER', 'fullName': 'Umberto I Hospital, Frosinone Italy'}, 'officialTitle': 'Goodness of Clinical History During Stemi PCI (GHOST)', 'orgStudyIdInfo': {'id': 'GHOST'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'STEMI patients treated with PCI', 'description': 'Four hundred patients with STEMI treated with primary PCI or rescue PCI.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frosinone', 'state': 'Frosinone', 'country': 'Italy', 'facility': 'Interventional cardiology divisione , Umberto I Hospital', 'geoPoint': {'lat': 41.63976, 'lon': 13.34109}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umberto I Hospital, Frosinone Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cardiology Division', 'investigatorFullName': 'Menichelli Maurizio', 'investigatorAffiliation': 'Umberto I Hospital, Frosinone Italy'}}}}