AF Stroke Substudy SL-ECG Versus 12lead ECG

March 9, 2020 updated by: RWTH Aachen University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North-Rhine-Westphalia
      • Aachen, North-Rhine-Westphalia, Germany, 52074
        • Uniklinium RWTH Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients and volunteers that meets the inclusion criteria and are not affected by the exclusion criteria are allowed to participate in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
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).
Diagnostic test: SL-ECG
additional SL-ECG measurement
Control Group
Fifty volunteers who did a 12lead-ECG measurement, repeat the procedure using the hand-held diagnostic tool (SL-ECG).
Diagnostic test: SL-ECG
additional SL-ECG measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the SL-ECG (hand-held diagnostic tool) with the 12lead-ECG (gold standard) to identify and evaluate cardiac arrhythmias.
Time Frame: 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.
12 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of SL-ECGs and validation of prognostic factors based person-specific data and their medical history.
Time Frame: 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.
12 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Nikolaus Marx, Head of the Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2018

Primary Completion (Actual)

March 26, 2019

Study Completion (Actual)

March 26, 2019

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-078

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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