AF Stroke Substudy SL-ECG Versus 12lead ECG

Completed

• Conditions: ECG; ECG Hand-held Diagnostic Tool; Atrial Fibrillation
• Interventions: Diagnostic Test: SL-ECG

• Registration Number: NCT03715361
• Lead Sponsor: RWTH Aachen University

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2018-10-09
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-23
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Comparison of the SL-ECG (hand-held diagnostic tool) with the 12lead-ECG (gold standard) to identify and evaluate cardiac arrhythmias.	12 Month	The 12lead-ECG and the measurement of the hand-held diagnostic tool, performed by the proband/volunteer after the main examination, are crucial for the examination. The ECG hand-held diagnostic tool measures the heartbeat by analyzing the RR-intervals and gives a direct indication of irregularities through a red light after the measurement. Preliminary analyses showed a very good signal quality of the SL-ECG, therefore the times \[s\] and amplitudes \[mV\] of the P-wave, QRS-complex, T-wave, as well as the conduction and excitation shall be compared with each other and evaluated.

Secondary Outcome Measures

Name	Time	Method
Analysis of SL-ECGs and validation of prognostic factors based person-specific data and their medical history.	12 Month	The descriptive analysis is performed comprehensively for the entire cohort and separately for people with known and newly discovered atrial fibrillation. The SL-ECG, person-specific data (e.g. age, BMI) and medical history (e.g. cardiovascular diseases, drug intake) are used to validate known prognostic factors and to find new prognostic factors. Continuous variables are summarized by calculating mean, median, standard deviation, quantiles and interquartile distances. For categorial variables, frequencies and percentages are calculated and tabulated. Based on these values, the raw incidence as well as age- and gender-specific incidences of atrial fibrillation can be calculated.

Trial Locations

Locations (1)

Uniklinium RWTH Aachen; 🇩🇪 Aachen, North-Rhine-Westphalia, Germany