Clinical trial NCT03627806: FLorida Puerto Rico Atrial Fibrillation Stroke Study (FLiPER-AF)
Official title: Disparities in Stroke Outcomes and Care Delivery in Patients With Atrial Fibrillation: FLorida Puerto Rico Atrial Fibrillation Stroke Study (FLiPER-AF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Disparities
Florida-Puerto Rico Stroke Registry
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2018-08-13
Enrollment: 104308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* age is 18 and older
* primary diagnosis of ischemic stroke
* enrolled in the Florida - Puerto Rico Stroke Registry

Exclusion Criteria:

* primary diagnosis of intracerebral hemorrhage
* diagnosis of subarachnoid hemorrhage
* stroke not otherwise specified
* no stroke related diagnosis
* admission for elective carotid intervention only

Primary outcomes:
measure: In-Hospital Quality of Care Acute Stroke Measures
timeFrame: 5 years
Secondary outcomes:
measure: Temporal trends of atrial fibrillation for stroke outcomes
timeFrame: 5 years
measure: Temporal trends in the frequency of hospital prescriptions at discharge of anticoagulants for stroke patients
timeFrame: 5 years
measure: Temporal trends in the frequency of hospital prescriptions for atrial fibrillation monitoring devices
timeFrame: 5 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Tatjana Rundek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.