Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

Stroke, Acute Clinical Trial

Official title:

Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700945
• Other study ID #: Stroke AF
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: July 28, 2022

Study information

• Verified date: April 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF) through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™ Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC) medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known origin.

Description:

Stroke AF is a prospective, multi-site, randomized, controlled, non-blinded, post-market study. The Stroke AF study will compare the incidence rate of atrial fibrillation through 12 months between the continuous monitoring arm and the control arm in subjects with a recent ischemic stroke of presumed known origin. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ Insertable Cardiac Monitor inserted within 10 days of the qualifying stroke and undergo continuous remote monitoring. Subjects randomized to the control arm will be followed per site specific standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: July 28, 2022
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days

• Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up

• Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke:

• Congestive heart failure

• Hypertension (Systolic Blood Pressure > 140)

• Diabetes Mellitus

• Prior Stroke (>90 days ago, other than study qualifying index event)

• Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque)

Exclusion Criteria:

• Subject has had a cryptogenic stroke

• Subject has had a cardioembolic stroke

• Subject has untreated hyperthyroidism

• Subject has had a recent myocardial infarction <1 month of stroke

• Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) <1 month of stroke

• Subject has a mechanical heart valve

• Subject has valvular disease requiring immediate surgical intervention

• Subject has documented prior history of atrial fibrillation or atrial flutter

• Subject has permanent indication for oral anticoagulation

• Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment

• Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee.

• Subject's life expectancy is less than 1 year

• Subject is pregnant

• Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable hemodynamic monitor

• Subject with a medical condition that precludes the patient from participation in the opinion of the investigator

Related Conditions & MeSH terms

• Atrial Fibrillation
• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

Device:
• Reveal LINQ™ Insertable Cardiac Monitor
The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Innovative Medical Research of South Florida	Aventura	Florida
United States	Cardiovascular Associates of the Southeast	Birmingham	Alabama
United States	Health Partners Institute (Bloomington MN)	Bloomington	Minnesota
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University at Buffalo, The State University of New York	Buffalo	New York
United States	Northwestern University	Chicago	Illinois
United States	Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)	Dallas	Texas
United States	University of Texas (UT) Southwestern Medical Center	Dallas	Texas
United States	Cone Health	Greensboro	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The Queens Medical Center	Honolulu	Hawaii
United States	Houston Methodist Hospital	Houston	Texas
United States	Scripps Memorial Hospital La Jolla	La Jolla	California
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Norton Neuroscience Institute	Louisville	Kentucky
United States	Centra Medical Group Stroobants Cardiovascular Center	Lynchburg	Virginia
United States	University of Miami Hospital	Miami	Florida
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Saint Thomas Research Institute	Nashville	Tennessee
United States	North Shore University Hospital	New Hyde Park	New York
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	AdventHealth Neuroscience Institute	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mercy Clinic Cardiology	Saint Louis	Missouri
United States	Health Partners Institute (Saint Louis Park MN)	Saint Louis Park	Minnesota
United States	University of California San Francisco UCSF Medical Center	San Francisco	California
United States	Cox Medical Center South	Springfield	Missouri
United States	PeaceHealth Sacred Heart Medical Center at Riverbend	Springfield	Oregon
United States	Overlook Medical Center	Summit	New York
United States	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin.	AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis.	12 months
Secondary	The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms.	AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis.	3 years