FLorida Puerto Rico Atrial Fibrillation Stroke Study (FLiPER-AF)

Atrial Fibrillation Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627806
• Other study ID #: CV185-564
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: January 1, 2021

Study information

• Verified date: January 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104308
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years
Secondary	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	5 years
Secondary	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	5 years
Secondary	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).	5 years