Trial Outcomes & Findings for Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke (NCT NCT02232022)

NCT ID: NCT02232022

Last Updated: 2019-07-30

Results Overview

The incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-07-30

Participant Flow

Participant milestones

Measure	NonCryptogenic Ischemic Stroke Patients In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017. Patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months. Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities.
Overall Study STARTED	53
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke

Baseline characteristics by cohort

Measure	NonCryptogenic Ischemic Stroke Patients n=53 Participants In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017, 53 patients were enrolled. 51/53 patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months. Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants
Age, Continuous	64.8 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants
Baseline AF Assessment	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

The incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.

Outcome measures

Measure	NonCryptogenic Ischemic Stroke n=51 Participants Reveal LINQ Insertable Cardiac Monitor
Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients	6 Participants

SECONDARY outcome

Timeframe: 1 year

Percentage of patients who are diagnosed with AF who are changed to anticoagulant therapy.

Outcome measures

Measure	NonCryptogenic Ischemic Stroke n=6 Participants Reveal LINQ Insertable Cardiac Monitor
Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy.	5 Participants

SECONDARY outcome

Timeframe: 1 year

Duration of AF episodes (mean and range).

Outcome measures

Measure	NonCryptogenic Ischemic Stroke n=6 Participants Reveal LINQ Insertable Cardiac Monitor
Duration of AF Episodes.	237 min Interval 1.0 to 1122.0

SECONDARY outcome

Timeframe: 1 year

Percentage of asymptomatic AF episodes.

Outcome measures

Measure	NonCryptogenic Ischemic Stroke n=6 Participants Reveal LINQ Insertable Cardiac Monitor
Percentage of Asymptomatic AF	6 Participants

SECONDARY outcome

Timeframe: 1 year

Incidence of recurrent ischemic stroke.

Outcome measures

Measure	NonCryptogenic Ischemic Stroke n=53 Participants Reveal LINQ Insertable Cardiac Monitor
Incidence of Recurrent Stroke	2 Participants

SECONDARY outcome

Timeframe: 1 year

Number of patients that had multiple AF episodes.

Outcome measures

Measure	NonCryptogenic Ischemic Stroke n=6 Participants Reveal LINQ Insertable Cardiac Monitor
Number of Patients That Had Multiple AF Episodes	4 Participants

Adverse Events

NonCryptogenic Ischemic Stroke Patients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	NonCryptogenic Ischemic Stroke Patients n=51 participants at risk Reveal LINQ Insertable Cardiac Monitor
Skin and subcutaneous tissue disorders Device Erosion	2.0% 1/51 • 3 years

Additional Information

Jeffrey M. Katz

Northwell Health

Phone: 516-562-3062

Email: jkatz2@northwell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place