Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-30 @ 4:56 AM
Study NCT ID:
NCT00456066
Status:
TERMINATED
Last Update Posted:
2008-10-08
First Post:
2007-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary Thromboaspiration and Infarct Size
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-07', 'studyFirstSubmitDate': '2007-04-03', 'studyFirstSubmitQcDate': '2007-04-03', 'lastUpdatePostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT', 'timeFrame': 'by ce-MRI and rest Tc99m-mibi gated SPECT'}], 'secondaryOutcomes': [{'measure': 'Probability of evolution toward left ventricular remodelling (defined as an increase of end-diastolic volume of>20% between the acute phase and 6-montcontrol)', 'timeFrame': 'of end-diastolic volumeof>20% between the acute phase and 6-montcontrol)'}]}, 'conditionsModule': {'keywords': ['Acute myocardial infarction', 'Thromboaspiration', 'Infarct size', 'Left ventricular remodelling'], 'conditions': ['Ischemic Heart Disease', 'Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Distal embolization can occur during coronary angioplasty performed in the acute phase of myocardial infarction and is associated with poor long-term outcome. We hypothesize that the use of a system allowing thrombus aspiration before angioplasty and stent implantation will limit infarct size and its severity.', 'detailedDescription': 'Patients scheduled for emergency angioplasty in the acute phase of a first ST-elevation myocardial infarction will be treated either by thromboaspiration followed by angioplasty or by angioplasty alone. The infarct size and severity will be assessed by ce-MRI and rest Tc99m-mibi gated SPECT performed during initial hospital stay (5th-8th day). A control MRI will be performed at 6-month follow-up to analyse the evolution of left ventricular volumes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute phase of myocardial infarction (\\>48 hours from the onset of chest pain)\n* stable hemodynamic conditions\n* completely occluded infarct related artery\n\nExclusion Criteria:\n\n* heart failure signs in the acute phase\n* contra indication for MRI or SPECT IMAGING'}, 'identificationModule': {'nctId': 'NCT00456066', 'briefTitle': 'Coronary Thromboaspiration and Infarct Size', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Assessment of Efficacity of Coronary Thromboaspiration (Export System) Performed Before Angioplasty on Infarct Size in Patients Treated by Coronary Percutaneous Interventions During Acute Phase.', 'orgStudyIdInfo': {'id': 'CHU63-0018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Export Aspiration System', 'type': 'DEVICE', 'description': 'Patients scheduled for emergency angioplasty'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'country': 'France', 'facility': 'Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Janusz Lipiecki, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Janusz LIPIECKI', 'oldOrganization': 'CHU Clermont-Ferrand'}}}}