Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-03-05 @ 5:41 AM
Study NCT ID:
NCT01870492
Status:
TERMINATED
Last Update Posted:
2017-03-03
First Post:
2013-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Patient Access to Stroke Therapy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'C473935', 'term': 'oxotris(2-pyridylmethyl)amineiron(IV)'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Principle Investigator relocated to a new institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2013-06-03', 'studyFirstSubmitQcDate': '2013-06-03', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of regional pre-hospital, hospital, and community barriers to stroke therapy', 'timeFrame': 'At end of study (12 months)'}], 'secondaryOutcomes': [{'measure': 'Total number of stroke patients treated with acute stroke therapy', 'timeFrame': 'At end of study (12 months)'}, {'measure': 'Total number of stroke patients eligible to receive Activase® versus patients eligible but did not receive Activase®', 'timeFrame': 'At end of study (12 months)'}, {'measure': 'Use of endovascular therapy in patients who received Activase® versus patients who did not receive Activase®', 'timeFrame': 'At end of study (12 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IV-tPA', 'Activase', 'endovascular therapy'], 'conditions': ['Ischemic Stroke', 'Transient Ischemic Attack']}, 'descriptionModule': {'briefSummary': 'Limited access is a major hurdle in the treatment of AIS; many hospitals, especially rural hospitals, do not have the infrastructure or medical support to effectively treat AIS patients.5 Failure to recognize the signs and symptoms of stroke by the patient and/or emergency medical services (EMS) is another barrier to the timely treatment of AIS. Several studies, including the Paul Coverdell National Acute Stroke Registry (PCNASR), have reported low rates of adherence to stroke care guidelines, suggesting that many AIS patients do not receive proper treatment according to established guidelines. Thus, there remains an increasing need to assess and address the barriers that prevent patient access to proper AIS treatment.\n\nAnnually, approximately 20,000 patients are discharged from Wisconsin hospitals with the diagnosis of stroke and an estimated 4,000 patients die from stroke each year in WI. To date, there have been no statewide studies initiated in Wisconsin to assess the regional barriers to the treatment of AIS patients with thrombolytic or endovascular therapy, and many hospitals do not routinely collect and analyze AIS patient data.\n\nThe goal of the Improving Patient Access to Stroke Therapy (IMPACT) pilot study is to engage community hospitals statewide to identify the regional barriers to AIS therapy in WI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with an acute ischemic stroke (AIS) or transient ischemic attack (TIA) and meet all of the inclusion and none of the exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Clinical diagnosis of acute ischemic stroke or transient ischemic attack (TIA)\n* ICD-9-CM code indicative of stroke or TIA\n\nExclusion Criteria:\n\n* Clinical diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage\n* Stroke or TIA occurred while patient was hospitalized'}, 'identificationModule': {'nctId': 'NCT01870492', 'acronym': 'IMPACT', 'briefTitle': 'Improving Patient Access to Stroke Therapy Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Improving Patient Access to Stroke Therapy Study', 'orgStudyIdInfo': {'id': '19978'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute ischemic stroke or TIA', 'description': 'Patients presenting with acute ischemic stroke or transient ischemic attack and underwent treatment using Activase and/or endovascular therapy.', 'interventionNames': ['Drug: Activase', 'Device: Endovascular therapy']}], 'interventions': [{'name': 'Activase', 'type': 'DRUG', 'otherNames': ['IV-tPA'], 'description': 'Patients treated with Activase', 'armGroupLabels': ['Acute ischemic stroke or TIA']}, {'name': 'Endovascular therapy', 'type': 'DEVICE', 'description': 'Patients treated with endovascular therapy, such as IA-tPA, mechanical thrombectomy, etc for acute ischemic stroke or transient ischemic attack.', 'armGroupLabels': ['Acute ischemic stroke or TIA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Osama O Zaidat, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}