Improving Patient Access to Stroke Therapy Study

Ischemic Stroke Clinical Trial

— IMPACT  

Official title:

Improving Patient Access to Stroke Therapy Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01870492
• Other study ID #: 19978
• Status: Terminated
• Phase: N/A
• First received: June 3, 2013
• Last updated: March 1, 2017
• Start date: January 2014
• Est. completion date: September 29, 2015

Study information

• Verified date: March 2017
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: September 29, 2015
• Est. primary completion date: September 29, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack

Intervention

Drug:
• Activase
Patients treated with Activase

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

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of regional pre-hospital, hospital, and community barriers to stroke therapy		At end of study (12 months)
Secondary	Total number of stroke patients treated with acute stroke therapy		At end of study (12 months)
Secondary	Total number of stroke patients eligible to receive Activase® versus patients eligible but did not receive Activase®		At end of study (12 months)
Secondary	Use of endovascular therapy in patients who received Activase® versus patients who did not receive Activase®		At end of study (12 months)