Atrial Fibrillation Screening With a Smartphone Device and iECG Application

Atrial Fibrillation Clinical Trial

— AFScreenCol  

Official title:

Atrial Fibrillation Screening With a Smartphone Device and iECG Application

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02534532
• Other study ID #: 18250
• Status: Withdrawn
• Phase: N/A
• First received: August 19, 2015
• Last updated: November 24, 2015
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• AF screening
Screening of AF in an opportunistic screening program using a smartphone device/application confirmed by ECG

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients screened in whom the screening device detect an abnormal cardiac rhythm		Up to 6 months	No
Primary	Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECG		Up to 6 months	No
Secondary	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	No

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