Atrial FibrillationFLiPER-AFNCT03627806
FLorida Puerto Rico Atrial Fibrillation Stroke Study (FLiPER-AF)
An observational study of Atrial Fibrillation, run by University of Miami at 1 site in United States.
Trial summary
In this study, FL-PR Stroke Registry will be used to determine novel data on disparities in stroke care and outcomes for patients with Atrial Fibrillation (AF) in 'real life' hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 104,308 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2010to 1 Jan 2021
- How long will I take part?
- 3 Years
- 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: The study population is derived from the Florida-Puerto Rico Stroke Registry to Reduce Stroke Disparities. In-hospital acute stroke performance measures are documented and obtained through the American Heart Association (AHA) Get With The Guidelines-Stroke (GWTG-S) premier hospital quality improvement program and GWTG-S data collection instruments. Through the GWTG-S data, the Registry currently has close to 169,000 patients enrolled since 2010.
Who may be able to join
- age is 18 and older
- primary diagnosis of ischemic stroke
- enrolled in the Florida - Puerto Rico Stroke Registry
Who cannot join
- primary diagnosis of intracerebral hemorrhage
- diagnosis of subarachnoid hemorrhage
- stroke not otherwise specified
- no stroke related diagnosis
- admission for elective carotid intervention only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disparities in Stroke Outcomes and Care Delivery in Patients With Atrial Fibrillation: FLorida Puerto Rico Atrial Fibrillation Stroke Study (FLiPER-AF)
In this study, FL-PR Stroke Registry will be used to determine novel data on disparities in stroke care and outcomes for patients with Atrial Fibrillation (AF) in 'real life' hospital setting. Investigators will evaluate clinical practice for AF detection and treatment in stroke patients within large stroke hospital systems of care with multi-ethnic patient populations and thereby representative of the states of Florida and Puerto Rico. The results of this study will be of critical importance for secondary stroke prevention by identifying gaps in stroke care for patients with AF and by recognizing the needs for developing targeted interventions to reduce disparities in diverse populations of stroke patients with AF and improve systems of care for all stroke patients with AF.
- Conditions
- Atrial Fibrillation
- Keywords
- Disparities, Florida-Puerto Rico Stroke Registry
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital Quality of Care Acute Stroke Measures
As measured by modified rankin score (mRS) at discharge (a score that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke). A minimum score of 0 indicates no symptoms and therefore no disability. A maximum score of 6 indicates death has resulted
Measured: 5 years
Secondary outcomes (3)
Temporal trends of atrial fibrillation for stroke outcomes
Changes in the occurrence of atrial fibrillation (AF) and its effect on related hospital discharge characteristics among stroke patients
Measured: 5 years
Temporal trends in the frequency of hospital prescriptions at discharge of anticoagulants for stroke patients
Changes over the years measured through the quantification of the frequency hospitals prescribe anticoagulants (i.e., aspirin, warfarin, and novel oral anticoagulants) at discharge
Measured: 5 years
Temporal trends in the frequency of hospital prescriptions for atrial fibrillation monitoring devices
Changes over the years measured through the quantification of the frequency hospitals prescribe atrial fibrillation monitoring devices (i.e., Holter monitoring and prolonged electrocardiogram monitoring).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Jan 2010
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Prospective
- Enrolment
- 104,308 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Tatjana Rundek, MD, PhD, University of Miami
- Investigators
- Tatjana Rundek, MD PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627806
- Sponsor's protocol ID
- CV185-564
- Acronym
- FLiPER-AF
- Status last verified
- Jan 2021
- First submitted
- 29 Apr 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sur NB, Wang K, Di Tullio MR, Gutierrez CM, Dong C, Koch S, Gardener H, Garcia-Rivera EJ, Zevallos JC, Burgin WS, Rose DZ, Goldberger JJ, Romano JG, Sacco RL, Rundek T. Disparities and Temporal Trends in the Use of Anticoagulation in Patients With Ischemic Stroke and Atrial Fibrillation. Stroke. 2019 Jun;50(6):1452-1459. doi: 10.1161/STROKEAHA.118.023959. Epub 2019 May 14.
PubMed 31084325
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disparities in Stroke Outcomes and Care Delivery in Patients With Atrial Fibrillation: FLorida Puerto Rico Atrial Fibrillation Stroke Study (FLiPER-AF)
- ClinicalTrials.gov ID
- NCT03627806
- Acronym / sponsor ID
- FLiPER-AF / CV185-564
- Conditions
- Atrial Fibrillation
- Keywords
- Disparities, Florida-Puerto Rico Stroke Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104,308 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 13 Aug 2018 (actual)
- 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.
In this study, FL-PR Stroke Registry will be used to determine novel data on disparities in stroke care and outcomes for patients with Atrial Fibrillation (AF) in 'real life' hospital setting. Investigators will evaluate clinical practice for AF detection and treatment in stroke patients within large stroke hospital systems of care with multi-ethnic patient populations and thereby representative of the states of Florida and Puerto Rico. The results of this study will be of critical importance for secondary stroke prevention by identifying gaps in stroke care for patients with AF and by recognizing the needs for developing targeted interventions to reduce disparities in diverse populations of stroke patients with AF and improve systems of care for all stroke patients with AF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is derived from the Florida-Puerto Rico Stroke Registry to Reduce Stroke Disparities. In-hospital acute stroke performance measures are documented and obtained through the American Heart Association (AHA) Get With The Guidelines-Stroke (GWTG-S) premier hospital quality improvement program and GWTG-S data collection instruments. Through the GWTG-S data, the Registry currently has close to 169,000 patients enrolled since 2010.
Key inclusion criteria (3 listed)
- age is 18 and older
- primary diagnosis of ischemic stroke
- enrolled in the Florida - Puerto Rico Stroke Registry
Key exclusion criteria (5 listed)
- primary diagnosis of intracerebral hemorrhage
- diagnosis of subarachnoid hemorrhage
- stroke not otherwise specified
- no stroke related diagnosis
- admission for elective carotid intervention only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-Hospital Quality of Care Acute Stroke Measures
Time frame: 5 years
As measured by modified rankin score (mRS) at discharge (a score that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke). A minimum score of 0 indicates no symptoms and therefore no disability. A maximum score of 6 indicates death has resulted
3 secondary outcomes
Temporal trends of atrial fibrillation for stroke outcomes
Time frame: 5 years
Temporal trends in the frequency of hospital prescriptions at discharge of anticoagulants for stroke patients
Time frame: 5 years
Temporal trends in the frequency of hospital prescriptions for atrial fibrillation monitoring devices
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Derived from this study: PubMed 31084325Sur NB, Wang K, Di Tullio MR, Gutierrez CM, Dong C, Koch S, Gardener H, Garcia-Rivera EJ, Zevallos JC, Burgin WS, Rose DZ, Goldberger JJ, Romano JG, Sacco RL, Rundek T. Disparities and Temporal Trends in the Use of Anticoagulation in Patients With Ischemic Stroke and Atrial Fibrillation. Stroke. 2019 Jun;50(6):1452-1459. doi: 10.1161/STROKEAHA.118.023959. Epub 2019 May 14.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Tatjana Rundek, MD PhD principal investigator
University of Miami
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 Atrial Fibrillation, run by University of Miami 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 5 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: finished, as of the sponsor's last update on 3 Feb 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In-Hospital Quality of Care Acute Stroke Measures (time frame: 5 years). 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 NCT03627806, which also lists 1 linked publication.
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 Feb 2021.