Improving Patient Access to Stroke Therapy Study

NCT01870492 | Terminated

• 1 other identifier: 19978
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

IV-tPA; Activase; endovascular therapy

Outcome Measures

Primary Outcomes (1)

• Identification of regional pre-hospital, hospital, and community barriers to stroke therapy

  At end of study (12 months)

Secondary Outcomes (3)

• Total number of stroke patients treated with acute stroke therapy

  At end of study (12 months)

• Total number of stroke patients eligible to receive Activase® versus patients eligible but did not receive Activase®

  At end of study (12 months)

• Use of endovascular therapy in patients who received Activase® versus patients who did not receive Activase®

  At end of study (12 months)

Study Arms (1)

Acute ischemic stroke or TIA

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

Drug: Activase; Device: Endovascular therapy

Interventions

Activase DRUG

Patients treated with Activase

Also known as: IV-tPA

Acute ischemic stroke or TIA

Endovascular therapy DEVICE

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

Acute ischemic stroke or TIA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Interventions

Tissue Plasminogen Activator; oxotris(2-pyridylmethyl)amineiron(IV)

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Osama O Zaidat, MD, MS

  Medical College Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 6, 2013
• Study Start: January 1, 2014
• Primary Completion: September 29, 2015
• Study Completion: September 29, 2015
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

US (1)