Atrial Fibrillation Screening With a Smartphone Device and iECG Application (AFScreenCol)

Question: Can atrial fibrillation (AF) cases in patients ≥ 65 years be easily detected in a primary healthcare environment using a smartphone device and iECG application as an opportunistic screening tool?

Objectives:

Detection of AF through cardiac rhythm abnormalities in patients ≥65 years old in an opportunistic screening program using a smartphone device/application

1. Define the predictable value of the smartphone device with electrocardiogram (ECG) confirmation to detect AF in patients 65 years and older
2. Correlate screened patients cardiovascular risk profile and those that register cardiac rhythm irregularities for a better description of the general characteristics of Colombian population

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: AF screening

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects included in the study are patients 65 years and older reaching programmed primary care counselling, and who are willingly to participate and do not present any exclusion criteria for the screening

Description

Inclusion Criteria:

• Females and males patients ≥65 years old attending primary care counselling
• Written informed consent

Exclusion Criteria:

• Patients with confirmed diagnosis of AF
• Patients who do not want to participate
• Patients consulting for acute conditions
• Patients presenting any diagnosed arrhythmia different than AF

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Females and males ≥65 years old, attending to the primary care centers, located in three different major cities in Colombia, that are willing to participate in the study, and do not present any exclusion criteria	Other: AF screening; Screening of AF in an opportunistic screening program using a smartphone device/application confirmed by ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients screened in whom the screening device detect an abnormal cardiac rhythm	Up to 6 months
Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECG	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECG	Predictive value tests - Positive: Number of patients screened in whom AF was confirmed with ECG/ Number of patients screened in whom the screening device detect an abnormal rhythm - Negative: Number of patients screened in whom AF was discarded with ECG/ Number of patients screened in whom the screening device detect an abnormal rhythm	Up to 6 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 26, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Estimate): November 25, 2015
• Last Update Submitted That Met QC Criteria: November 24, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Atrial fibrillation screening
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 18250