Clinical trial NCT03715361: AF Stroke Substudy SL-ECG Versus 12lead ECG
Official title: AF Stroke Substudy SL-ECG Versus 12lead ECG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ECG
Atrial Fibrillation
ECG Hand-held Diagnostic Tool
Keywords: ECG measurement
AF-Stroke
Germany
Electrocardiogram
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-10-23
Enrollment: 550
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of the SL-ECG (hand-held diagnostic tool) with the 12lead-ECG (gold standard) to identify and evaluate cardiac arrhythmias.
timeFrame: 12 Month
Secondary outcomes:
measure: Analysis of SL-ECGs and validation of prognostic factors based person-specific data and their medical history.
timeFrame: 12 Month
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinium RWTH Aachen
state: North-Rhine-Westphalia
Study officials:
affiliation: Head of the Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine
name: Nikolaus Marx
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0735-1097(00)01107-4.
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. doi: 10.1161/01.CIR.0000140263.20897.42. Epub 2004 Aug 16.
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.
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. doi: 10.1016/s0002-9343(02)01236-6.
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. doi: 10.1161/01.str.22.8.983.