AF Stroke Substudy SL-ECG Versus 12lead ECG

RWTH Aachen University

Status: Completed

Conditions: ECG; Atrial Fibrillation; ECG Hand-held Diagnostic Tool

Treatments: Diagnostic Test: SL-ECG

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03715361

18-078

Details and patient eligibility

About

The purpose of the study is to compare parameters obtained per SL-ECG with the values from 12lead-ECG measurement. Patients who undergo out- or inpatient treatment and who receive a 12lead-ECG are asked to participate in this examination. Furthermore, 50 patients without heart disease should be included (control group).

Full description

Atrial fibrillation is the most common cardiac arrhythmia in Germany. Clinical studies have shown that atrial fibrillation is associated with increased morbidity and mortality and reduced quality of life. Patients with atrial fibrillation have a three times higher risk of heart failure and a four to five times higher risk of ischemic stroke. In addition to these risks, atrial fibrillation is often asymptomatic and therefore more difficult to diagnose. It is estimated that about one third of all atrial fibrillation patients are asymptomatic.

For this reason, the study "Opportunistic Screening in Pharmacies for Atrial Fibrillation in Seniors" was conducted in Aachen. Within four weeks more than 7000 volunteers could be measured in participating pharmacies using a ECG hand-held diagnostic tool. Since the already measured subjects only have the SL-ECG measurement of the hand-held diagnostic tool, the aim of this substudy is to establish a reference group. In this reference group a 12lead-ECG is performed by routine ECG and a SL-ECG measurement by ECG hand-held diagnostic tool. The aim of the study is to compare the measured parameters and to optimize the algorithm to evaluate the remaining SL-ECGs of the main study.

Enrollment: 550 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient is 18 years old, for minors the signature of the legal guardian is required.
• Understanding of the essence, meaning and scope of the study.
• Patients (in-/outpatient) who receive a 12lead ECG through Medical Clinic 1.
• Volunteers who are willing to have a 12lead ECG and an SL-ECG performed and provide medical information.
• Signed informed consent

Exclusion criteria

• Insufficient language skills
• Limited cognitive abilities
• Limited physical abilities (i.e. tremor)

Trial design

550 participants in 2 patient groups

Patients

Description:

Patients (500 patients ≤ ) who undergo out- or inpatient treatment and who did a 12lead-ECG measurement, repeat the procedure using the hand-held diagnostic tool (SL-ECG).

Treatment:

Diagnostic Test: SL-ECG

Control Group

Description:

Fifty volunteers who did a 12lead-ECG measurement, repeat the procedure using the hand-held diagnostic tool (SL-ECG).

Treatment:

Diagnostic Test: SL-ECG