Trials / Completed
CompletedNCT03715361
AF Stroke Substudy SL-ECG Versus 12lead ECG
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 550 (actual)
- Sponsor
- RWTH Aachen University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | SL-ECG | additional SL-ECG measurement |
Timeline
- Start date
- 2018-10-09
- Primary completion
- 2019-03-26
- Completion
- 2019-03-26
- First posted
- 2018-10-23
- Last updated
- 2020-03-10
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03715361. Inclusion in this directory is not an endorsement.