AF Stroke Substudy SL-ECG Versus 12lead ECG

NCT03715361 | Completed

• 1 other identifier: 18-078
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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).

Conditions

ECG; Atrial Fibrillation; ECG Hand-held Diagnostic Tool

Keywords

ECG measurement; AF-Stroke; Germany; Electrocardiogram

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Analysis of SL-ECGs and validation of prognostic factors based person-specific data and their medical history.

  12 Month

Study Arms (2)

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

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

Interventions

SL-ECG DIAGNOSTIC_TEST

additional SL-ECG measurement

Control Group; Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Insufficient language skills
• Limited cognitive abilities
• Limited physical abilities (i.e. tremor)

Sponsors & Collaborators

• RWTH Aachen University: lead
• Pfizer: collaborator

Study Sites (1)

Uniklinium RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related 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. doi: 10.1016/s0735-1097(00)01107-4.

  PMID: 11216949 BACKGROUND

• 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.

  PMID: 15313941 BACKGROUND

• 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.

  PMID: 22577476 BACKGROUND

• 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.

  PMID: 12401529 BACKGROUND

• 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.

  PMID: 1866765 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nikolaus Marx

  Head of the Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 23, 2018
• Study Start: October 9, 2018
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

DE (1)