Continuous EKG Monitoring Using S-Patch Ex : Prospective Observational Study (S-patch Registry)

Atrial fibrillation (AF) is associated with increased mortality and morbidity, and is a dominant, yet preventable, cause of cardioembolic stroke, which has more severe outcomes than other ischaemic stroke causes if left untreated. Approximately 10% of ischemic strokes are associated with AF (AF) first diagnosed at the time of stroke. Detecting asymptomatic AF would provide an opportunity to prevent these strokes by instituting appropriate anticoagulation.

Early diagnosis of AF might enable oral anticoagulant therapy and prevent unwanted consequences of undetected disease, leading to the suggestion that screening for AF might be beneficial in populations at risk. However, there is still debate about whether screen-detected AF bears a similar stroke and mortality risk profile to clinically detected AF, particularly when AF screening is done at a higher intensity than single-time point.

The absence of studies reporting on hard clinical endpoints in AF screening has led to differences in recommendations globally. Most notably, systematic screening for AF is to be considered according to 2020 European guidelines, whereas the US Preventive Services Task Force concluded that current evidence is insufficient to assess the balance of benefits and harms of screening for AF.

The incidence of screen-detected AF strongly depends on the population screened and duration/intensity of screening. Single-time point screening of a general population ≥65 years of age detects undiagnosed AF in 1.4%, and the AF detected is largely persistent. In a large population-based study of individuals 75 to 76 years of age, a more intense 2-week screening program using twice-daily intermittent handheld ECG recordings identified AF in 3.0% (0.5% on the initial ECG4). The identical protocol restricted to those with ≥1 additional stroke risk factor identified 7.4% with AF.

This study was designed in to two arms. The purpose of Arm 1 is to upgrade the artificial intelligence by collecting the continued ECG monitoring data in patients with previous diagnosed AF. The purpose of Arm 2 is to investigate the detection rate of AF using systematic, intensive AF screening with continuous ECG monitoring and the rate of clinical outcome in individuals at high risk during one year follow-up.

Study Overview

• Status: Recruiting
• Conditions: Patient With Atrial Fibrillation or High Stroke Risk
• Intervention / Treatment: Device: continous 3 day EKG monitoring with S-Patch Cardio

Detailed Description

Arm 1 Patients with AF are examined with 72 hour continued ECG monitoring Arm 2 Patients with high stroke risk (CHA2DS2-VASc score >=2) are examined with 72 hour continued ECG monitoring

• Study Type: Observational
• Enrollment (Anticipated): 2450

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Referred patients in tertiary care clinic

Description

Inclusion Criteria:

1. Patients who are over the age of 19
2. Those with previous diagnosis of atrial fibrillation
3. Those without atrial fibrillation, but high stroke risk

Exclusion Criteria:

1. Those who refuse to participate in the trial.
2. Those without internet connection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with atrial fibrillation; Patients with previous diagnosis of atrial fibrillation	Device: continous 3 day EKG monitoring with S-Patch Cardio; continous 3 day EKG monitoring with S-Patch Cardio
Non-AF patients with high stroke risk	Device: continous 3 day EKG monitoring with S-Patch Cardio; continous 3 day EKG monitoring with S-Patch Cardio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of partipants with atrial fibrillation	presence of atrial fibrillation	At the end of continous ECG monitoring up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome	composite outcome (all-cause mortality, stroke, transient ischemic accident, systemic embolism, cardiac arrest)	1 year
Acquisition rate of ECG	Acquisition rate of ECG signal for 72 hours	Acquisition rate of ECG signal for 72 hours
Quality of Life	Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire: 20 questions, scare from 1 (better outcome) to 7 (worse outcome).	At the enrollment
Cognitive function	Korean Dementia Screening Questionnaire (KDSQ) questionnaire: 25 questions, scare form 1 (better oucome) to 3 (worse outcome)	At the enrollment

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2021
• Primary Completion (ANTICIPATED): February 1, 2023
• Study Completion (ANTICIPATED): February 1, 2023

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (ACTUAL): November 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: stroke; atrial fibrillation; risk; continuous; EKG
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 1-2021-0002

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