AF Stroke Substudy SL-ECG Versus 12lead ECG

Atrial Fibrillation Clinical Trial

Official title:

AF Stroke Substudy SL-ECG Versus 12lead ECG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715361
• Other study ID #: 18-078
• Status: Completed
• Start date: October 9, 2018
• Est. completion date: March 26, 2019

Study information

• Verified date: March 2020
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• ECG
• ECG Hand-held Diagnostic Tool

Intervention

Diagnostic Test:
• SL-ECG
additional SL-ECG measurement

Locations

Country	Name	City	State
Germany	Uniklinium RWTH Aachen	Aachen	North-Rhine-Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Chugh SS, Blackshear JL, Shen WK, Hammill SC, Gersh BJ. Epidemiology and natural history of atrial fibrillation: clinical implications. J Am Coll Cardiol. 2001 Feb;37(2):371-8. Review. — View Citation

Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D'Agostino RB, Massaro JM, Beiser A, Wolf PA, Benjamin EJ. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004 Aug 31;110(9):1042-6. Epub 2004 Aug 16. — View Citation

Schnabel RB, Wilde S, Wild PS, Munzel T, Blankenberg S. Atrial fibrillation: its prevalence and risk factor profile in the German general population. Dtsch Arztebl Int. 2012 Apr;109(16):293-9. doi: 10.3238/arztebl.2012.0293. Epub 2012 Apr 20. — View Citation

Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. — View Citation

Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the SL-ECG (hand-held diagnostic tool) with the 12lead-ECG (gold standard) to identify and evaluate cardiac arrhythmias.	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	Analysis of SL-ECGs and validation of prognostic factors based person-specific data and their medical history.	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

External Links

•   www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.114.014343