StrokeGWTG-StrokeNCT02693223
Get With the Guidelines-Stroke Registry
An observational study of Stroke, run by American Heart Association at 1 site in United States.
Trial summary
Get With The Guidelines-Stroke is a program for improving the quality of care for patients hospitalized with stroke by promoting consistent adherence to the latest evidence-based clinical practice guidelines. Read more about this study
- Who is it for?
- Ages 18 to 125 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- GWTG Stroke program
- How many people
- 3,892,063 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 2040
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 125 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a diagnosis of Ischemic stroke or transient ischemic attack, Subarachnoid hemorrhage, Intracerebral hemorrhage, or Stroke not otherwise specified.
Who may be able to join
- Patients presented with a diagnosis of Ischemic stroke or transient ischemic attack, Subarachnoid hemorrhage, Intracerebral hemorrhage, or Stroke not otherwise specified to the hosptials.
Who cannot join
- Patients who do not have a diagnosis of Ischemic stroke or transient ischemic attack, Subarachnoid hemorrhage, Intracerebral hemorrhage, or Stroke not otherwise specified.
- Patients under age of 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christine Rutan contact
United States1 site, 1 recruiting
- Recruiting
Amy Bennett
Dallas, Texas, 75231
Amy Bennett, JD, 214-706-4881, amy.bennett@heart.org
Christine Rutan, Christine.Rutan@heart.org
About this study
Get With The Guidelines-Stroke is a program for improving the quality of care for patients hospitalized with stroke by promoting consistent adherence to the latest evidence-based clinical practice guidelines.
Read the detailed description
Get With The Guidelines®-Stroke is an in-hospital program for improving stroke care by promoting consistent adherence to the latest scientific treatment guidelines. Since its initiation in 2003, 2,637 hospitals have entered 3,892,063 patient records into the Get With The Guidelines-Stroke database. Numerous published studies demonstrate the program's success in achieving measurable patient outcome improvements.
Achievement measures tracked through the Get With The Guidelines®-Stroke:
- IV rT-PA arrive by 3.5 hour, treat by 4.5hour
- Early antithrombotics
- VTE prophylaxis
- Antithrombotics at or by discharge
- Anticoagulation for Afib/Aflutter at or by discharge
- Smoking cessation at or by discharge
- Intensive Statin Therapy
Quality measures tracked through the Get With The Guidelines®-Stroke:
- Dysphagia screen
- Time to intravenous thrombolytic therapy-60 min
- NIHSS reported
- Stroke education at or by discharge
- Rehabilitation considered at or by discharge
- LDL Documented
Additional measures collected by Get With The Guidelines®-Stroke can be viewed at: https://www.heart.org/en/professional/quality-improvement/get-with-the-guidelines/get-with-the-guidelines-stroke/get-with-the-guidelines-stroke-patient-management-tool
- Conditions
- Stroke
- Being tested
- GWTG Stroke program
- Keywords
- stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWTG Stroke programOther
Evidence based recommended therapies and counseling prior to hospital discharge.
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: 6 days - mean for length of hospitalization for Stroke patients
Modified Rankin Scale at Discharge
Patients grouped by Modified Rankin Scale at discharge
Measured: 6 days - mean for length of hospitalization for Stroke patients
Risk-Adjusted Mortality Ratio (for Ischemic-Only and Ischemic and Hemorrhagic models)
A ratio comparing the actual in-hospital mortality rate to the risk-adjusted expected mortality rate.
Measured: 30 days post discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startJan 2003
- Primary completionJan 2040 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 3,892,063 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- American Heart Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javed Butler, MD, Study director, American Heart Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693223
- Sponsor's protocol ID
- 001
- Acronym
- GWTG-Stroke
- Status last verified
- Jan 2025
- First submitted
- 23 Feb 2016
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Mulder MJ, van Oostenbrugge RJ, Dippel DW; MR CLEAN Investigators. Letter by Mulder et al Regarding Article, "2015 AHA/ASA Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association". Stroke. 2015 Nov;46(11):e235. doi: 10.1161/STROKEAHA.115.010913. Epub 2015 Oct 8. No abstract available.
PubMed 26451021Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.
PubMed 26022637Meschia JF, Bushnell C, Boden-Albala B, Braun LT, Bravata DM, Chaturvedi S, Creager MA, Eckel RH, Elkind MS, Fornage M, Goldstein LB, Greenberg SM, Horvath SE, Iadecola C, Jauch EC, Moore WS, Wilson JA; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Functional Genomics and Translational Biology; Council on Hypertension. Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Dec;45(12):3754-832. doi: 10.1161/STR.0000000000000046. Epub 2014 Oct 28.
PubMed 25355838Saver JL, Carroll JD, Smalling R, Thaler D. Letter by Saver et al regarding article, "Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association". Stroke. 2015 Apr;46(4):e85-6. doi: 10.1161/STROKEAHA.115.007311. Epub 2015 Mar 5. No abstract available.
PubMed 25744518Powers WJ, Derdeyn CP, Biller J, Coffey CS, Hoh BL, Jauch EC, Johnston KC, Johnston SC, Khalessi AA, Kidwell CS, Meschia JF, Ovbiagele B, Yavagal DR; American Heart Association Stroke Council. 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Oct;46(10):3020-35. doi: 10.1161/STR.0000000000000074. Epub 2015 Jun 29.
PubMed 26123479
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get With the Guidelines-Stroke Registry
- ClinicalTrials.gov ID
- NCT02693223
- Acronym / sponsor ID
- GWTG-Stroke / 001
- Conditions
- Stroke
- Keywords
- stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,892,063 participants (estimated)
- Lead sponsor
- American Heart AssociationUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2040 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 26 Feb 2016 (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.
Get With The Guidelines-Stroke is a program for improving the quality of care for patients hospitalized with stroke by promoting consistent adherence to the latest evidence-based clinical practice guidelines.
Detailed description
Get With The Guidelines®-Stroke is an in-hospital program for improving stroke care by promoting consistent adherence to the latest scientific treatment guidelines. Since its initiation in 2003, 2,637 hospitals have entered 3,892,063 patient records into the Get With The Guidelines-Stroke database. Numerous published studies demonstrate the program's success in achieving measurable patient outcome improvements.
Achievement measures tracked through the Get With The Guidelines®-Stroke:
- IV rT-PA arrive by 3.5 hour, treat by 4.5hour
- Early antithrombotics
- VTE prophylaxis
- Antithrombotics at or by discharge
- Anticoagulation for Afib/Aflutter at or by discharge
- Smoking cessation at or by discharge
- Intensive Statin Therapy
Quality measures tracked through the Get With The Guidelines®-Stroke:
- Dysphagia screen
- Time to intravenous thrombolytic therapy-60 min
- NIHSS reported
- Stroke education at or by discharge
- Rehabilitation considered at or by discharge
- LDL Documented
Additional measures collected by Get With The Guidelines®-Stroke can be viewed at: https://www.heart.org/en/professional/quality-improvement/get-with-the-guidelines/get-with-the-guidelines-stroke/get-with-the-guidelines-stroke-patient-management-tool
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of Ischemic stroke or transient ischemic attack, Subarachnoid hemorrhage, Intracerebral hemorrhage, or Stroke not otherwise specified.
Key inclusion criteria (1 listed)
- Patients presented with a diagnosis of Ischemic stroke or transient ischemic attack, Subarachnoid hemorrhage, Intracerebral hemorrhage, or Stroke not otherwise specified to the hosptials.
Key exclusion criteria (2 listed)
- Patients who do not have a diagnosis of Ischemic stroke or transient ischemic attack, Subarachnoid hemorrhage, Intracerebral hemorrhage, or Stroke not otherwise specified.
- Patients under age of 18
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 |
|---|---|---|
| GWTG Stroke programEvidence based recommended therapies and counseling prior to hospital discharge. | Other | – |
Primary outcome
In-hospital mortality
Time frame: 6 days - mean for length of hospitalization for Stroke patients
Modified Rankin Scale at Discharge
Time frame: 6 days - mean for length of hospitalization for Stroke patients
Patients grouped by Modified Rankin Scale at discharge
Risk-Adjusted Mortality Ratio (for Ischemic-Only and Ischemic and Hemorrhagic models)
Time frame: 30 days post discharge from hospital
A ratio comparing the actual in-hospital mortality rate to the risk-adjusted expected mortality rate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Results publication: PubMed 26451021Mulder MJ, van Oostenbrugge RJ, Dippel DW; MR CLEAN Investigators. Letter by Mulder et al Regarding Article, "2015 AHA/ASA Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association". Stroke. 2015 Nov;46(11):e235. doi: 10.1161/STROKEAHA.115.010913. Epub 2015 Oct 8. No abstract available.
- Results publication: PubMed 26022637Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.
- Results publication: PubMed 25355838Meschia JF, Bushnell C, Boden-Albala B, Braun LT, Bravata DM, Chaturvedi S, Creager MA, Eckel RH, Elkind MS, Fornage M, Goldstein LB, Greenberg SM, Horvath SE, Iadecola C, Jauch EC, Moore WS, Wilson JA; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Functional Genomics and Translational Biology; Council on Hypertension. Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Dec;45(12):3754-832. doi: 10.1161/STR.0000000000000046. Epub 2014 Oct 28.
- Results publication: PubMed 25744518Saver JL, Carroll JD, Smalling R, Thaler D. Letter by Saver et al regarding article, "Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association". Stroke. 2015 Apr;46(4):e85-6. doi: 10.1161/STROKEAHA.115.007311. Epub 2015 Mar 5. No abstract available.
- Results publication: PubMed 26123479Powers WJ, Derdeyn CP, Biller J, Coffey CS, Hoh BL, Jauch EC, Johnston KC, Johnston SC, Khalessi AA, Kidwell CS, Meschia JF, Ovbiagele B, Yavagal DR; American Heart Association Stroke Council. 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Oct;46(10):3020-35. doi: 10.1161/STR.0000000000000074. Epub 2015 Jun 29.
- Individual participant dataSharing planned: Undecided
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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.
Christine Rutan contact
Javed Butler, MD study director
American Heart Association
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 Stroke, run by American Heart Association 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 1 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Bennett, JD (2147064881, amy.bennett@heart.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: 6 days - mean for length of hospitalization for Stroke patients). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02693223, which also lists 5 linked publications.
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 29 Jan 2025.