ECGNCT03715361
AF Stroke Substudy SL-ECG Versus 12lead ECG
An observational study of ECG and Atrial Fibrillation, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- ECG, Atrial Fibrillation, ECG Hand-held Diagnostic Tool
- What is being tested?
- SL-ECG
- How many people
- 550 participants
- Where
- 1 siteGermany
- Study dates
- 9 Oct 2018to 26 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Insufficient language skills
- Limited cognitive abilities
- Limited physical abilities (i.e. tremor)
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- ECG, Atrial Fibrillation, ECG Hand-held Diagnostic Tool
- Being tested
- SL-ECG
- Keywords
- ECG measurement, AF-Stroke, Germany, Electrocardiogram
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL-ECGDiagnostic test
additional SL-ECG measurement
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Diagnostic Test: SL-ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Month
Secondary outcomes (1)
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.
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start9 Oct 2018
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ECGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Nikolaus Marx, Principal investigator, Head of the Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715361
- Sponsor's protocol ID
- 18-078
- Status last verified
- Mar 2020
- First submitted
- 11 Oct 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. doi: 10.1016/s0735-1097(00)01107-4.
PubMed 11216949Lloyd-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.
PubMed 15313941Schnabel 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.
PubMed 22577476Stewart 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.
PubMed 12401529Wolf 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.
PubMed 1866765
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AF Stroke Substudy SL-ECG Versus 12lead ECG
- ClinicalTrials.gov ID
- NCT03715361
- Acronym / sponsor ID
- 18-078
- Conditions
- ECG, Atrial Fibrillation, ECG Hand-held Diagnostic Tool
- Keywords
- ECG measurement, AF-Stroke, Germany, Electrocardiogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: SL-ECGPatients (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). |
| Control Group | – | Diagnostic Test: SL-ECGFifty volunteers who did a 12lead-ECG measurement, repeat the procedure using the hand-held diagnostic tool (SL-ECG). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Insufficient language skills
- Limited cognitive abilities
- Limited physical abilities (i.e. tremor)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SL-ECGadditional SL-ECG measurement | Diagnostic test | Control Group, Patients |
Primary outcome
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.
1 secondary outcome
Analysis of SL-ECGs and validation of prognostic factors based person-specific data and their medical history.
Time frame: 12 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 11216949Chugh 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.
- Background: PubMed 15313941Lloyd-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.
- Background: PubMed 22577476Schnabel 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.
- Background: PubMed 12401529Stewart 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.
- Background: PubMed 1866765Wolf 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.
- www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.114.014343Link provided by the sponsor.
Related trials for ECG
RecruitingObservational study
Clinical Performance and Usability of the Heart Rate and Impedance Respiration Monitor Cable
Monitoring, ECG
RecruitingObservational study
Artificial Intelligence-assisted Evaluation of Pulmonary HYpertension
Pulmonary Hypertension, Pulmonary Arterial Hypertension
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
Not yet recruitingObservational study
Merlin Expanded ECG NSR
Heart Failure, Bradycardia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaus Marx principal investigator
Head of the Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ECG and Atrial Fibrillation, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715361, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.