AF Stroke Substudy SL-ECG Versus 12lead ECG

• ClinicalTrials.gov Identifier: NCT03715361
• Recruitment Status: Completed
• First Posted: October 23, 2018
• Last Update Posted: March 10, 2020
• Sponsor: RWTH Aachen University
• Collaborator: Pfizer
• Information provided by (Responsible Party): RWTH Aachen University

Study Description

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).

Condition or disease	Intervention/treatment
ECG; Atrial Fibrillation; ECG Hand-held Diagnostic Tool	Diagnostic Test: SL-ECG

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 Design

• Study Type: Observational
• Actual Enrollment: 550 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: AF Stroke Substudy SL-ECG Versus 12lead ECG
• Actual Study Start Date: October 9, 2018
• Actual Primary Completion Date: March 26, 2019
• Actual Study Completion Date: March 26, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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)

Contacts and Locations

Locations

Germany

Uniklinium RWTH Aachen

Aachen, North-Rhine-Westphalia, Germany, 52074

Sponsors and Collaborators

RWTH Aachen University

Pfizer

Investigators

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

More Information

Additional Information:

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

Publications:

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.

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.

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.

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.

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.

• Responsible Party: RWTH Aachen University
• ClinicalTrials.gov Identifier: NCT03715361
• Other Study ID Numbers: 18-078
• First Posted: October 23, 2018
• Last Update Posted: March 10, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RWTH Aachen University:

ECG measurement; AF-Stroke; Germany; Electrocardiogram

Additional relevant MeSH terms:

Atrial Fibrillation; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes