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

January 29, 2021 updated by: Tatjana Rundek, MD, PhD, University of Miami

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

104308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporal trends of atrial fibrillation for stroke outcomes
Time Frame: 5 years
Changes in the occurrence of atrial fibrillation (AF) and its effect on related hospital discharge characteristics among stroke patients
5 years
Temporal trends in the frequency of hospital prescriptions at discharge of anticoagulants for stroke patients
Time Frame: 5 years
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
Temporal trends in the frequency of hospital prescriptions for atrial fibrillation monitoring devices
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Tatjana Rundek, MD PhD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

April 29, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe