Trial Condition(s):
Atrial Fibrillation
Atrial fibrillation screening with a smartphone device and iECG application (AFScreenCol)
Bayer Identifier:
18250
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
Inclusion Criteria
- Females and males patients ≥65 years old attending primary care counselling
- Written informed consentExclusion 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 AFTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
|---|
Trial Design
Atrial fibrillation screening with a smartphone device and iECG application
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of patients screened in whom the screening device detect an abnormal cardiac rhythmTimeframe: Up to 6 months
- Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECGTimeframe: Up to 6 months
Secondary Outcome
- Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECGPredictive 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 rhythmTimeframe: Up to 6 months
Additional Information
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