Coronary Heart DiseaseEVERNCT02094989
ECG and VCG in Dependence of Body Posture
An observational study of Coronary Heart Disease and Arrhythmia, run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial summary
The electrocardiogram (ECG) is an important diagnostic procedure in medicine mainly to detect circulation disorders and problems of the spread of the electrical heart impulse. It is frequently the first measure in clinical practice when angina pectoris, acute myocardial infarction or an arrhythmia are suspected. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Arrhythmia
- What is being tested?
- posture dependence of VCG-ECG-transformation
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2013to Mar 2013
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: healthy men without history of cardiac disorder
Who may be able to join
- Subjects included in the study must meet the following criteria:
- Male aged 18 - 60 years
- Body Mass Index: 18.5 - 35 (WHO: normal weight - overweight - class I obesity)
- Basic pulse rate: 60 - 100 beats per minute
- Blood pressure: max. systolic 140 / diastolic 90 mm Hg
Who cannot join
- Chronic or acute disease (including drug abuse, bronchial asthma, pulmonary emphysema, COPD)
- Cardiac disease or limitations of the heart function (angina pectoris, previous myocardial infarction, arrhythmia, dyspnea)
- Implants for the treatment of acute and/or chronic diseases
- Regular intake of medication (> 2 per week) for the treatment of acute and/or chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Observational Controlled Trial to Assess the Statistical and the Visual Accuracy of the Individual VCG-ECG-Transformation in Dependence of Posture
The electrocardiogram (ECG) is an important diagnostic procedure in medicine mainly to detect circulation disorders and problems of the spread of the electrical heart impulse. It is frequently the first measure in clinical practice when angina pectoris, acute myocardial infarction or an arrhythmia are suspected. The ECG is easy to perform, safe and cheap.
Posture changes are known to cause alterations of the ECG [1]. Deviation of the electrical heart axis (EHA) [2], temporary changes of the QRS morphology and ST-segment alterations are of particular importance in view of diagnostic accuracy [3], [4]. In ambulatory ECG recordings ST-segment alterations for instance might mistakenly be interpreted as cardiac ischemia [5]. Artifacts could be minimized by the concurrent determination of the deviation of the electrical heart axis [6] [7]or by using posture detectors [8] helping to correlate ECG changes to posture changes.
Read more
Due to the emergence of new computer based opportunities ambulatory ECG in the sense of home monitoring is an emerging market. Together with the superiority compared to the scalar ECG in detecting certain pathologies, like myocardial infarction and right ventricular hypertrophy, the VCG gained new interest in recent years [9]. Four ECG leads are sufficient to synthesize a standard 12-lead ECG from a VCG and vice versa with a transformation matrix [10] [11].The redirection of the spatial VCG after posture changes has been determined for the QRS loop with the Frank leads, which is the reference method for constructing the VCG [12][13].
4 leads of an ambulatory ECG are sufficient to construct the VCG if arranged approximately in the position of three rectangular axes. Doctors are best trained to interpret standard 12 lead ECGs. With optimization of the leads of ambulatory (Holter) ECG towards the three rectangular axes, this might allow mathematical transformation into the standard 12 lead ECG. A precondition would be that the transformation matrix is independent of posture. To date, transformation matrix between Frank VCG and standard 12 lead ECG has only been calculated in resting ECGs [5].
This is the first study which investigates the transformation matrix in different postures. Additionally, the investigators will investigate for the first time prospectively for known artefacts of stress testing and ambulatory ECGs.
Aim:
Simultaneous prospective recording of the standard 12 lead ECG and the Frank-lead VCG in different postures is expected to add information on potential causes of artifacts of the ECG caused by posture changes. During continuous recording, the investigators will investigate the accuracy of the linear affine transformation with posture, the occurrence (dimension and duration) of ECG/ VCG morphology changes and ST-segment alterations, and VCG angle changes in dependence of posture changes in healthy young men.
Hypothesis The investigators hypothesis is that the transformation matrix between Frank-Lead VCG and standard 12-lead ECG is posture dependent.
Artefacts of the ECG due to posture changes are systematic. The knowledge of the systematics improves the diagnostic accuracy of ambulatory ECG and stress testing.
- Conditions
- Coronary Heart Disease, Arrhythmia
- Being tested
- posture dependence of VCG-ECG-transformation
- Keywords
- electrocardiogram, vectorcardiogram, telecardiology, linear regression, individual transformation matrix, posture
- Medical subject headings
- Coronary Disease, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posture dependence of VCG-ECG-transformationOther
| Study group | Role | What they receive |
|---|---|---|
| diagnostic | Not described Receives: Other: posture dependence of VCG-ECG-transformation |
What is being measured
The primary outcome is the main question the study is designed to answer.
posture dependence of the individual VCG-ECG-Transformation matrix
The transformation matrix will be defined as independent of posture, if the accuracy between measured and calculated 12 lead ECG of each posture vary below the accuracy level as defined in IEC 60601-1-52.
Measured: N/A (one simultaneous ECG/VCG record over 20 minutes)
Secondary outcomes (2)
artifacts in the ECG morphology
Posture changes will be defined as not being a relevant artifact for QRS morphology- and ST-segment alterations, if the accuracy between the supine standard 12 lead ECG and the measured 12 lead ECG of another posture vary below the accuracy level as defined in IEC 60601-1-52.
Measured: N/A (one simultaneous ECG/VCG record over 20 minutes)
posture dependence of electrical heart axis
The mean, range and standard deviation (SD) of angle changes of the electrical heart axis of each posture of all participants will be calculated.
Measured: N/A (one simultaneous ECG/VCG record over 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Oberholzer, Bern University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094989
- Sponsor's protocol ID
- BFH-001
- Acronym
- EVER
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Controlled Trial to Assess the Statistical and the Visual Accuracy of the Individual VCG-ECG-Transformation in Dependence of Posture
- ClinicalTrials.gov ID
- NCT02094989
- Acronym / sponsor ID
- EVER / BFH-001
- Conditions
- Coronary Heart Disease, Arrhythmia
- Keywords
- electrocardiogram, vectorcardiogram, telecardiology, linear regression, individual transformation matrix, posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 Mar 2014 (estimated)
- 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 electrocardiogram (ECG) is an important diagnostic procedure in medicine mainly to detect circulation disorders and problems of the spread of the electrical heart impulse. It is frequently the first measure in clinical practice when angina pectoris, acute myocardial infarction or an arrhythmia are suspected. The ECG is easy to perform, safe and cheap.
Posture changes are known to cause alterations of the ECG [1]. Deviation of the electrical heart axis (EHA) [2], temporary changes of the QRS morphology and ST-segment alterations are of particular importance in view of diagnostic accuracy [3], [4]. In ambulatory ECG recordings ST-segment alterations for instance might mistakenly be interpreted as cardiac ischemia [5]. Artifacts could be minimized by the concurrent determination of the deviation of the electrical heart axis [6] [7]or by using posture detectors [8] helping to correlate ECG changes to posture changes.
Due to the emergence of new computer based opportunities ambulatory ECG in the sense of home monitoring is an emerging market. Together with the superiority compared to the scalar ECG in detecting certain pathologies, like myocardial infarction and right ventricular hypertrophy, the VCG gained new interest in recent years [9]. Four ECG leads are sufficient to synthesize a standard 12-lead ECG from a VCG and vice versa with a transformation matrix [10] [11].The redirection of the spatial VCG after posture changes has been determined for the QRS loop with the Frank leads, which is the reference method for constructing the VCG [12][13].
4 leads of an ambulatory ECG are sufficient to construct the VCG if arranged approximately in the position of three rectangular axes. Doctors are best trained to interpret standard 12 lead ECGs. With optimization of the leads of ambulatory (Holter) ECG towards the three rectangular axes, this might allow mathematical transformation into the standard 12 lead ECG. A precondition would be that the transformation matrix is independent of posture. To date, transformation matrix between Frank VCG and standard 12 lead ECG has only been calculated in resting ECGs [5].
This is the first study which investigates the transformation matrix in different postures. Additionally, the investigators will investigate for the first time prospectively for known artefacts of stress testing and ambulatory ECGs.
Aim:
Simultaneous prospective recording of the standard 12 lead ECG and the Frank-lead VCG in different postures is expected to add information on potential causes of artifacts of the ECG caused by posture changes. During continuous recording, the investigators will investigate the accuracy of the linear affine transformation with posture, the occurrence (dimension and duration) of ECG/ VCG morphology changes and ST-segment alterations, and VCG angle changes in dependence of posture changes in healthy young men.
Hypothesis The investigators hypothesis is that the transformation matrix between Frank-Lead VCG and standard 12-lead ECG is posture dependent.
Artefacts of the ECG due to posture changes are systematic. The knowledge of the systematics improves the diagnostic accuracy of ambulatory ECG and stress testing.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic | – | Other: posture dependence of VCG-ECG-transformation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy men without history of cardiac disorder
Key inclusion criteria (5 listed)
- Subjects included in the study must meet the following criteria:
- Male aged 18 - 60 years
- Body Mass Index: 18.5 - 35 (WHO: normal weight - overweight - class I obesity)
- Basic pulse rate: 60 - 100 beats per minute
- Blood pressure: max. systolic 140 / diastolic 90 mm Hg
Key exclusion criteria (4 listed)
- Chronic or acute disease (including drug abuse, bronchial asthma, pulmonary emphysema, COPD)
- Cardiac disease or limitations of the heart function (angina pectoris, previous myocardial infarction, arrhythmia, dyspnea)
- Implants for the treatment of acute and/or chronic diseases
- Regular intake of medication (> 2 per week) for the treatment of acute and/or chronic diseases
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 |
|---|---|---|
| posture dependence of VCG-ECG-transformation | Other | diagnostic |
Primary outcome
posture dependence of the individual VCG-ECG-Transformation matrix
Time frame: N/A (one simultaneous ECG/VCG record over 20 minutes)
The transformation matrix will be defined as independent of posture, if the accuracy between measured and calculated 12 lead ECG of each posture vary below the accuracy level as defined in IEC 60601-1-52.
2 secondary outcomes
artifacts in the ECG morphology
Time frame: N/A (one simultaneous ECG/VCG record over 20 minutes)
posture dependence of electrical heart axis
Time frame: N/A (one simultaneous ECG/VCG record over 20 minutes)
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 24 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Heart Disease and Arrhythmia, run by Bern University of Applied Sciences at 1 site in Switzerland.
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 4 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 24 Mar 2014. 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 Switzerland. 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?
posture dependence of the individual VCG-ECG-Transformation matrix (time frame: N/A (one simultaneous ECG/VCG record over 20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2014.