Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT00379418
Status:
COMPLETED
Last Update Posted:
2013-09-12
First Post:
2006-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077284', 'term': 'Abciximab'}], 'ancestors': [{'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-11', 'studyFirstSubmitDate': '2006-09-19', 'studyFirstSubmitQcDate': '2006-09-20', 'lastUpdatePostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': "AIR STUDY\n\nTITLE: Anti-Ischemic effects of Abciximab(Reopro)\n\nPATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable statin dose or not on a statin. Statin= cholesterol lowering drug(ie, lipitor, zocor).\n\nINTERVENTION: Heparin vs. heparin + abciximab during PCI\n\nPURPOSE: Measure the effects of abciximab on special healing blood stem cells (EPC's-Endothelial Progenitor Cells), on inflammation, on oxidative stress and on microvascular blood flow.\n\nPATIENT ASSESSMENT:\n\n1. 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.\n2. Measurement of blood flow in selected suitable patients\n3. 10 minute questionnaire before discharge and on visit on day 28."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with coronary artery disease undergoing left heart catheterization', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have either:\n\n * clinical history of anginal symptoms or positive stress test or\n * in stent restenosis\n2. Have an angiographic \\>70% coronary artery stenosis that will be treated with coronary angioplasty or stenting procedure\n3. For at least four weeks prior to the procedure have been on, no Hmgcoa- reductase inhibitor or a stable statin dose\n4. negative pregnancy test\n5. are able to give informed consent\n\nExclusion Criteria:\n\n1. Coronary intervention within four weeks prior to enrollment.\n2. Treatment with abciximab antagonist within four weeks.\n3. treatment with thrombolytic therapy within 48 hours\n4. MI within 2 months.\n5. recent infections\n6. general anesthesia within 3 months.\n7. renal failure'}, 'identificationModule': {'nctId': 'NCT00379418', 'acronym': 'AIR', 'briefTitle': 'Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)', 'orgStudyIdInfo': {'id': 'IRB00021864'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Abciximab', 'type': 'DRUG', 'otherNames': ['Reopro']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30033', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Arshed A Quyyumi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EUH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kreton Mavromatis, MD, FACC', 'investigatorAffiliation': 'Emory University'}}}}