Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00931502
Status:
COMPLETED
Last Update Posted:
2018-03-02
First Post:
2009-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stent Thrombosis In Acute Coronary Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2009-06-29', 'studyFirstSubmitQcDate': '2009-06-30', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe current real world practice in the treatment of ACS due to stent thrombosis.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'To describe early and long term follow up of patients who are treated for ACS due to stent thrombosis.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stent thrombosis', 'Acute Coronary Syndrome', 'ACS', 'Stenting', 'Interventional Cardiology', 'Cardiology', 'Cardiovascular Research', 'Registry'], 'conditions': ['Stent Thrombosis', 'Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '24753053', 'type': 'DERIVED', 'citation': 'Reeves RR, Patel M, Armstrong EJ, Sab S, Waldo SW, Yeo KK, Shunk KA, Low RI, Rogers JH, Mahmud E. Angiographic characteristics of definite stent thrombosis: role of thrombus grade, collaterals, epicardial coronary flow, and myocardial perfusion. Catheter Cardiovasc Interv. 2015 Jan 1;85(1):13-22. doi: 10.1002/ccd.25519. Epub 2014 May 7.'}, {'pmid': '23703925', 'type': 'DERIVED', 'citation': 'Waldo SW, Armstrong EJ, Yeo KK, Patel M, Reeves R, Macgregor JS, Low RI, Mahmud E, Rogers JH, Shunk K. Procedural success and long-term outcomes of aspiration thrombectomy for the treatment of stent thrombosis. Catheter Cardiovasc Interv. 2013 Dec 1;82(7):1048-53. doi: 10.1002/ccd.25007. Epub 2013 Jul 2.'}, {'pmid': '22230151', 'type': 'DERIVED', 'citation': 'Armstrong EJ, Yeo KK, Javed U, Mahmud E, Patel M, Shunk KA, MacGregor JS, Low RI, Rogers JH. Angiographic stent thrombosis at coronary bifurcations: short- and long-term prognosis. JACC Cardiovasc Interv. 2012 Jan;5(1):57-63. doi: 10.1016/j.jcin.2011.09.015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to better understand what treatment methods result in the best outcomes for patients who have heart attacks due to blood clots forming within stents.', 'detailedDescription': 'This is a multicenter registry that examines treatment strategies and outcomes in patients who present with acute coronary syndrome (ACS) due to stent thrombosis in the coronary arteries. This study will take place at potentially 8 medical centers throughout the State of California. A total of 800 patients will be enrolled into the registry, 100 patients from each of the eight participating California medical centers. UC Davis will serve as the core lab for this study.\n\nEligible subjects, patients who present to the hospital (medical center) with ACS due to stent thrombosis and receive a cardiac catheterization to treat the stent thrombosis, will be included in the retrospective analysis of this cardiac condition. Subjects who expire in hospital due to ACS with stent thrombosis will also be included in the retrospective analysis of this clinical registry. Patients, who consent for approval, will become eligible to participate in the 3-year prospective follow-up phase of the clinical registry. These patients will be followed for three years to learn more about long term clinical outcomes for this disease state.\n\nThere are no specific/special procedures required for this clinical registry. This is a registry for data collection only to correlate prescribed medical care with individual short- and long-term clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have had a heart attack or almost have had a heart attack due to blood clots forming within previously placed stents.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject's age range will be ≥ 18 years old.\n* Subjects will have an existing drug-eluting or bare metal stent.\n* Subjects will have presented to the Medical Center with Acute Coronary Syndrome due to stent thrombosis as identified via cardiac catheterization.\n\nExclusion Criteria:\n\n* Inability to consent/declined to participate in the prospective arm of the clinical registry."}, 'identificationModule': {'nctId': 'NCT00931502', 'briefTitle': 'Stent Thrombosis In Acute Coronary Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Contemporary Treatment Of Stent Thrombosis In Acute Coronary Syndromes', 'orgStudyIdInfo': {'id': '214693'}, 'secondaryIdInfos': [{'id': 'STR 001'}, {'id': '214693', 'type': 'OTHER', 'domain': 'UC Davis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Jason Rogers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'Khung Keong Yeo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}