Atrial Fibrillation Screening With a Smartphone Device and iECG Application

NCT02534532 | Withdrawn

• 1 other identifier: 18250
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. 1.Define the predictable value of the smartphone device with electrocardiogram (ECG) confirmation to detect AF in patients 65 years and older
2. 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

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation screening

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECG

  Up to 6 months

Study Arms (1)

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

Interventions

AF screening OTHER

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

Cohort 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 27, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 25, 2015

Record last verified: 2015-11