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AFScreenCol: Atrial Fibrillation Screening With a Smartphone Device and iECG Application

Sponsor
Bayer (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02534532
Collaborator
(none)
0
Enrollment
6
Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Other: AF screening

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Time Perspective:
Cross-Sectional
Official Title:
Atrial Fibrillation Screening With a Smartphone Device and iECG Application
Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Apr 1, 2016
Anticipated Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Number of patients screened in whom the screening device detect an abnormal cardiac rhythm [Up to 6 months]

  2. Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECG [Up to 6 months]

Secondary Outcome Measures

  1. Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECG [Up to 6 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT02534532
Other Study ID Numbers:
  • 18250
First Posted:
Aug 27, 2015
Last Update Posted:
Nov 25, 2015
Last Verified:
Nov 1, 2015
Keywords provided by Bayer
Atrial fibrillation screening
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Nov 25, 2015