NCT03627806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104,308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

11 years

First QC Date

April 29, 2018

Last Update Submit

January 29, 2021

Conditions

Atrial Fibrillation

Keywords

DisparitiesFlorida-Puerto Rico Stroke Registry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Temporal trends of atrial fibrillation for stroke outcomes

    5 years

  • Temporal trends in the frequency of hospital prescriptions at discharge of anticoagulants for stroke patients

    5 years

  • Temporal trends in the frequency of hospital prescriptions for atrial fibrillation monitoring devices

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • 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.

    PMID: 31084325DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tatjana Rundek, MD PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2018

First Posted

August 13, 2018

Study Start

January 1, 2010

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

February 3, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)