Improving Patient Access to Stroke Therapy Study

NCT ID: NCT01870492

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-09-29

Brief Summary

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.

Annually, 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.

The 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.

Conditions

Ischemic Stroke; Transient Ischemic Attack

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Acute ischemic stroke or TIA

Patients presenting with acute ischemic stroke or transient ischemic attack and underwent treatment using Activase and/or endovascular therapy.

Activase

Intervention Type: DRUG

Patients treated with Activase

Endovascular therapy

Intervention Type: DEVICE

Patients treated with endovascular therapy, such as IA-tPA, mechanical thrombectomy, etc for acute ischemic stroke or transient ischemic attack.

Interventions

Activase

Patients treated with Activase

Intervention Type: DRUG

Endovascular therapy

Patients treated with endovascular therapy, such as IA-tPA, mechanical thrombectomy, etc for acute ischemic stroke or transient ischemic attack.

Intervention Type: DEVICE

Other Intervention Names

IV-tPA

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Clinical diagnosis of acute ischemic stroke or transient ischemic attack (TIA)
• ICD-9-CM code indicative of stroke or TIA

Exclusion Criteria

• Clinical diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage
• Stroke or TIA occurred while patient was hospitalized

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Osama O Zaidat, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Medical College Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

19978

Identifier Type: -

Identifier Source: org_study_id