Ischemic StrokeIMPACTNCT01870492
Improving Patient Access to Stroke Therapy Study
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Medical College of Wisconsin at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- Activase and Endovascular therapy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 29 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 years
- Clinical diagnosis of acute ischemic stroke or transient ischemic attack (TIA)
- ICD-9-CM code indicative of stroke or TIA
Who cannot join
- Clinical diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage
- Stroke or TIA occurred while patient was hospitalized
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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
- Being tested
- Activase, Endovascular therapy
- Keywords
- IV-tPA, Activase, endovascular therapy
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivaseDrug
Also called IV-tPA
Patients treated with Activase
Endovascular therapyDevice
Patients treated with endovascular therapy, such as IA-tPA, mechanical thrombectomy, etc for acute ischemic stroke or transient ischemic attack.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke or TIA | Patients presenting with acute ischemic stroke or transient ischemic attack and underwent treatment using Activase and/or endovascular therapy. Receives: Drug: Activase; Device: Endovascular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of regional pre-hospital, hospital, and community barriers to stroke therapy
Measured: At end of study (12 months)
Secondary outcomes (3)
Total number of stroke patients treated with acute stroke therapy
Measured: At end of study (12 months)
Total number of stroke patients eligible to receive Activase® versus patients eligible but did not receive Activase®
Measured: At end of study (12 months)
Use of endovascular therapy in patients who received Activase® versus patients who did not receive Activase®
Measured: At end of study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJan 2014
- Primary completion29 Sep 2015
- Study completion29 Sep 2015
Why it stopped: Principle Investigator relocated to a new institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama O Zaidat, MD, MS, Principal investigator, Medical College Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870492
- Sponsor's protocol ID
- 19978
- Acronym
- IMPACT
- Status last verified
- Mar 2017
- First submitted
- 3 Jun 2013
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Access to Stroke Therapy Study
- ClinicalTrials.gov ID
- NCT01870492
- Acronym / sponsor ID
- IMPACT / 19978
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Keywords
- IV-tPA, Activase, endovascular therapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principle Investigator relocated to a new institution
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 29 Sep 2015 (actual)
- Study completion
- 29 Sep 2015 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke or TIA | – | Drug: Activase, Device: Endovascular therapyPatients presenting with acute ischemic stroke or transient ischemic attack and underwent treatment using Activase and/or endovascular therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age > 18 years
- Clinical diagnosis of acute ischemic stroke or transient ischemic attack (TIA)
- ICD-9-CM code indicative of stroke or TIA
Key exclusion criteria (2 listed)
- Clinical diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage
- Stroke or TIA occurred while patient was hospitalized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActivaseAlso: IV-tPAPatients treated with Activase | Drug | Acute ischemic stroke or TIA |
| Endovascular therapyPatients treated with endovascular therapy, such as IA-tPA, mechanical thrombectomy, etc for acute ischemic stroke or transient ischemic attack. | Device | Acute ischemic stroke or TIA |
Primary outcome
Identification of regional pre-hospital, hospital, and community barriers to stroke therapy
Time frame: At end of study (12 months)
3 secondary outcomes
Total number of stroke patients treated with acute stroke therapy
Time frame: At end of study (12 months)
Total number of stroke patients eligible to receive Activase® versus patients eligible but did not receive Activase®
Time frame: At end of study (12 months)
Use of endovascular therapy in patients who received Activase® versus patients who did not receive Activase®
Time frame: At end of study (12 months)
Results and safety
The study was stopped early (reason given: Principle Investigator relocated to a new institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama O Zaidat, MD, MS principal investigator
Medical College Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principle Investigator relocated to a new institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of regional pre-hospital, hospital, and community barriers to stroke therapy (time frame: At end of study (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017; AzTrials last refreshed its copy on 1 Nov 2026.