Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 4:04 AM
Study NCT ID:
NCT00905294
Status:
TERMINATED
Last Update Posted:
2013-06-19
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Coronary Artery Disease
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': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Funding withdrawn', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels', 'timeFrame': 'change from baseline to after percutaneous coronary intervention', 'description': 'Assess the relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels in subjects with coronary artery disease prior to and after undergoing PCI in this exploratory study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine the relationship between proteins and enzymes in the blood and how they work with platelets to form blood clots in patients with coronary artery disease. The investigators hypothesize that the relationship between these factors could potentially be useful in identifying patients at higher risk for heart attacks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease undergoing percutaneous coronary intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to hospital with suspected index event of Non-ST-Elevation Myocardial Infarction (NSTEMI), Unstable Angina (UA) or Stable Angina (SA)\n* Planned percutaneous coronary intervention during admission\n\nExclusion Criteria:\n\n* Recent history (\\< 6 months) of an acute coronary syndrome (other than current admission) or stroke\n* Recent history (\\< 6 months) of major surgery, trauma or thromboembolic event\n* Percutaneous coronary or peripheral intervention or any stent placement performed within the past 6 months\n* Current evidence of infection'}, 'identificationModule': {'nctId': 'NCT00905294', 'acronym': 'ADVANCE-PCI', 'briefTitle': 'Study of ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'University College Cork'}, 'officialTitle': 'ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Patients Undergoing Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'INFACTs 2009-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coronary artery disease', 'description': 'Subjects with coronary artery disease undergoing percutaneous coronary intervention', 'interventionNames': ['Other: Blood draws']}], 'interventions': [{'name': 'Blood draws', 'type': 'OTHER', 'description': 'Observational: blood draws only', 'armGroupLabels': ['coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cork', 'country': 'Ireland', 'facility': 'Cork University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Noel M. Caplice, M.D, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Cork, Ireland'}, {'name': 'Dermot Kenny, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Royal College Surgeons in Ireland'}, {'name': 'David Foley, M.B.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beaumont Hospital, Dublin, Ireland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Cork', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal College of Surgeons, Ireland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Cardiovascular Sciences', 'investigatorFullName': 'Professor Noel Caplice', 'investigatorAffiliation': 'University College Cork'}}}}