Coronary Artery DiseaseEC vs TTENCT02702063
Calibrating Cardiac Output Measurement of Electrical Cardiometry With Transthoracic Echocardiography
A study testing passive leg raising test, right heart catheterisation and TTE vs. EC + calibration group in people with Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Cardiac output (CO) is a key variable when describing the cardiovascular system. Electrical cardiometry (EC) is a non-invasive method in measuring stroke volume and cardiac output. However, its accuracy has been inconsistent. Therefore Martin et al. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- passive leg raising test, right heart catheterisation and TTE vs. EC + calibration group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2015to Dec 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age above 18 years
- able to understand study procedure
Who cannot join
- aortic regurgitation
- congenital heart disease with intracardiac shunt
- arrhythmia
- withdrawing consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna
Vienna, State of Vienna, 1080
Ortner, MD, MSC, 0431404004100, clemens.ortner@meduniwien.ac.at
Clemens Ortner, MD, MSC
About this study
Cardiac output (CO) is a key variable when describing the cardiovascular system. Electrical cardiometry (EC) is a non-invasive method in measuring stroke volume and cardiac output. However, its accuracy has been inconsistent. Therefore Martin et al. have compared measurements with echocardiographic measurements and propose calibration with left ventricle outflow tract (LVOT)-measurements obtained from transthoracic echocardiography (TTE). This study was performed in pregnant women at term. Goal of this study is to validate their formula in non-pregnant outpatients undergoing echocardiography for cardiology work-up. Secondary aim is to perform a leg raising test and to compare changes in stroke volume observed with either EC or TTE.
Read the detailed description
Cardiac output (CO) is a key variable when describing and treating the cardiovascular system. The ideal cardiac output (CO) monitor would be safe, non-invasive, low-cost, painless, easy to interpret and would allow for the continuous, hands-free acquisition of accurate data. Electrical cardiometry (EC), a more recent version of impedance cardiography (ICG), meets many of the criteria for an ideal monitor and previously published research suggests that EC successfully trends CO1-3, but its accuracy in measuring absolute values of stroke volume (SV) has been inconsistent in published research4-8. Electrical cardiometry works by sending an insensible high frequency alternating current through the thorax and measures changes in thoracic impedance that are attributed to systolic blood flow acceleration over the cardiac cycle. Using fiducial points in the tracing of the first derivative of impedance, EC calculates left ventricular ejection time (LVET) and mean velocity of blood during systole. By further estimating a patient constant that is primarily based on body mass ('volume of electrically participating tissue' (VEPT)), stroke volume is estimated in the following way:
- SVEC = VEPT * Mean blood velocity * corrected Flow Time (FTc).
Cardiac output monitors are typically validated against a reference standard, which has traditionally been thermodilution using a pulmonary artery catheter (PAC). Given the risks associated with the use of pulmonary artery catheters9 an alternative method, such as transthoracic echocardiography (TTE), lends itself as valuable substitute technique for measuring CO. Transthoracic echocardiography is safe, painless and non-invasive. Similarly to EC, SV estimate by TTE is based on a measurement of mean blood velocity and ejection time (mean blood velocity x ejection time = velocity time integral, VTI; (Figure 3)). However, in contrast to EC, the parameters for blood velocity and left ventricular ejection time are not multiplied with a normative patient constant, but with a measured parameter: the left ventricular outflow tract area (LVOT area):
- SVTTE = LVOT area * mean blood velocity * ejection time. Main disadvantage of using TTE for CO-measurement is advanced training that is needed to obtain VTI measurements and that it is highly labor intense to obtain repeated VTIs for continuous or repeated CO measurements. Measurement of LVOT area, by contrast, is a one-time measurement obtained from parasternal long axis view, which necessitates only basic training of TTE.
Recently Martin and colleagues10 compared SV parameters derived from EC and TTE in a sample of 44 healthy pregnant volunteers and found excellent agreement in mean left ventricular ejection time and heart rate. However, agreement in SV was poor with a percentage error of 42% in Bland-Altman analysis. Hypothesizing that both methodologies in estimating SV, EC and TTE, use measures for blood velocity and systolic ejection time, Martin et al. hypothesized that agreement between both methods could be significantly improved by calibrating SV-EC with the LVOT area that is derived from one time TTE measurement. Based on a multiplicative linear regression model and following log-linear transformation Martin et al. derived the following formula for calibration:
SVEC_Modified = 2.2 * LVOT_area(0.705) * SV_EC(0.388) * Weight(0.21) By applying this formula, agreement in SV measurements significantly improved and percentage error decreased to 22 %. However, data was derived from a very specific patient population (pregnant women) and accuracy of the modified SV-assessment was not validated in a prospective manner.
Therefore, this study proposes to compare SV-estimates derived from EC and TTE in non-pregnant outpatients undergoing routine echocardiography assessment. Primary aim of this study is to evaluate if agreement between both methods can be improved by calibrating SV-measurements obtained from electrocardiometry with a one-time LVOT area measurement obtained from TTE.
Secondary aim will be to perform passive leg raising test and compare sensitivity in both identifying fluid responsiveness between both monitoring methodologies.
Third aim is to compare CO derived measurements from EC and TTE with gold standard measurements derived from patients undergoing routine right heart catheterisation for evaluation of cardiac and pulmonary function.
- Conditions
- Coronary Artery Disease
- Being tested
- passive leg raising test, right heart catheterisation, TTE vs. EC + calibration group
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive leg raising testOther
Patients undergoing routine echocardiography are exposed to a passive leg raising test. Change in SV will be measured by TTE and compared to changes in SV measured by EC.
right heart catheterisationProcedure or surgery
CO in patients undergoing routine right heart catheterisation will be measured and compared between 3 methodologies: right heart catheterisation, TTE and EC
TTE vs. EC + calibration groupOther
Patients will undergo routine echocardiography. CO and SV will be measured by TTE and compared to measurements obtained from simultaneous EC-measurements.
| Study group | Role | What they receive |
|---|---|---|
| TTE vs. EC + calibration group | Other | 50 Patients undergoing routine transthoracic echocardiography at laboratory for transthoracic echocardiography at the department of cardiology of Medical University Vienna will be enrolled following informed consent. Non-inclusion criteria are inability to understand study procedure and age under 18 years old.
Patients with any grade of aortic regurgitation, congenital heart disease with intracardiac shunt (left-right shunt or right-left shunt) or arrhythmia (atrial fibrillation) or withdrawing consent during study procedure will be excluded. In addition, patients with intraabdominal (IAH), intracranial (ICH) hypertension or any disease of the hip joint, will not be included into the trial. Receives: Other: TTE vs. EC + calibration group |
| Right heart catheterisation | Other | Twenty five patients undergoing routine right heart catheterization (RHC) at the department of cardiology for the evaluation of suspected pulmonary hypertension or heart failure will be included in this trial. EC measurements will be obtained during RHC, and a TTE (for measuring LVOT-area) will be performed immediately before undergoing RHC. Inclusion and exclusion criteria are similar as described above. Receives: Procedure: right heart catheterisation |
| Passive leg raising test | Other | 50 Patients undergoing routine transthoracic echocardiography at laboratory for transthoracic echocardiography at the department of cardiology of Medical University Vienna will be enrolled following informed consent. Non-inclusion criteria are inability to understand study procedure and age under 18 years old.
Patients with any grade of aortic regurgitation, congenital heart disease with intracardiac shunt (left-right shunt or right-left shunt) or arrhythmia (atrial fibrillation) or withdrawing consent during study procedure will be excluded. In addition, patients with intraabdominal (IAH), intracranial (ICH) hypertension or any disease of the hip joint, will not be included into the trial.
SV and CO will be measured using TTE and EC. Patient's legs will then be raised by 45degree, and SV and CO measurements will be repeated after 1 minute. Changes in SV and CO observed with both methods will be compared. Receives: Other: passive leg raising test |
What is being measured
The primary outcome is the main question the study is designed to answer.
agreement Stroke volume
SV measured by TTE, RHC and EC will be compared
Measured: 3 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Clemens Ortner, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702063
- Sponsor's protocol ID
- MUVienna 1139/2015
- Acronym
- EC vs TTE
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibrating Cardiac Output Measurement of Electrical Cardiometry With Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT02702063
- Acronym / sponsor ID
- EC vs TTE / MUVienna 1139/2015
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Mar 2016 (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.
Cardiac output (CO) is a key variable when describing the cardiovascular system. Electrical cardiometry (EC) is a non-invasive method in measuring stroke volume and cardiac output. However, its accuracy has been inconsistent. Therefore Martin et al. have compared measurements with echocardiographic measurements and propose calibration with left ventricle outflow tract (LVOT)-measurements obtained from transthoracic echocardiography (TTE). This study was performed in pregnant women at term. Goal of this study is to validate their formula in non-pregnant outpatients undergoing echocardiography for cardiology work-up. Secondary aim is to perform a leg raising test and to compare changes in stroke volume observed with either EC or TTE.
Detailed description
Cardiac output (CO) is a key variable when describing and treating the cardiovascular system. The ideal cardiac output (CO) monitor would be safe, non-invasive, low-cost, painless, easy to interpret and would allow for the continuous, hands-free acquisition of accurate data. Electrical cardiometry (EC), a more recent version of impedance cardiography (ICG), meets many of the criteria for an ideal monitor and previously published research suggests that EC successfully trends CO1-3, but its accuracy in measuring absolute values of stroke volume (SV) has been inconsistent in published research4-8. Electrical cardiometry works by sending an insensible high frequency alternating current through the thorax and measures changes in thoracic impedance that are attributed to systolic blood flow acceleration over the cardiac cycle. Using fiducial points in the tracing of the first derivative of impedance, EC calculates left ventricular ejection time (LVET) and mean velocity of blood during systole. By further estimating a patient constant that is primarily based on body mass ('volume of electrically participating tissue' (VEPT)), stroke volume is estimated in the following way:
- SVEC = VEPT * Mean blood velocity * corrected Flow Time (FTc).
Cardiac output monitors are typically validated against a reference standard, which has traditionally been thermodilution using a pulmonary artery catheter (PAC). Given the risks associated with the use of pulmonary artery catheters9 an alternative method, such as transthoracic echocardiography (TTE), lends itself as valuable substitute technique for measuring CO. Transthoracic echocardiography is safe, painless and non-invasive. Similarly to EC, SV estimate by TTE is based on a measurement of mean blood velocity and ejection time (mean blood velocity x ejection time = velocity time integral, VTI; (Figure 3)). However, in contrast to EC, the parameters for blood velocity and left ventricular ejection time are not multiplied with a normative patient constant, but with a measured parameter: the left ventricular outflow tract area (LVOT area):
- SVTTE = LVOT area * mean blood velocity * ejection time. Main disadvantage of using TTE for CO-measurement is advanced training that is needed to obtain VTI measurements and that it is highly labor intense to obtain repeated VTIs for continuous or repeated CO measurements. Measurement of LVOT area, by contrast, is a one-time measurement obtained from parasternal long axis view, which necessitates only basic training of TTE.
Recently Martin and colleagues10 compared SV parameters derived from EC and TTE in a sample of 44 healthy pregnant volunteers and found excellent agreement in mean left ventricular ejection time and heart rate. However, agreement in SV was poor with a percentage error of 42% in Bland-Altman analysis. Hypothesizing that both methodologies in estimating SV, EC and TTE, use measures for blood velocity and systolic ejection time, Martin et al. hypothesized that agreement between both methods could be significantly improved by calibrating SV-EC with the LVOT area that is derived from one time TTE measurement. Based on a multiplicative linear regression model and following log-linear transformation Martin et al. derived the following formula for calibration:
SVEC_Modified = 2.2 * LVOT_area(0.705) * SV_EC(0.388) * Weight(0.21) By applying this formula, agreement in SV measurements significantly improved and percentage error decreased to 22 %. However, data was derived from a very specific patient population (pregnant women) and accuracy of the modified SV-assessment was not validated in a prospective manner.
Therefore, this study proposes to compare SV-estimates derived from EC and TTE in non-pregnant outpatients undergoing routine echocardiography assessment. Primary aim of this study is to evaluate if agreement between both methods can be improved by calibrating SV-measurements obtained from electrocardiometry with a one-time LVOT area measurement obtained from TTE.
Secondary aim will be to perform passive leg raising test and compare sensitivity in both identifying fluid responsiveness between both monitoring methodologies.
Third aim is to compare CO derived measurements from EC and TTE with gold standard measurements derived from patients undergoing routine right heart catheterisation for evaluation of cardiac and pulmonary function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TTE vs. EC + calibration group | Other | Other: TTE vs. EC + calibration group50 Patients undergoing routine transthoracic echocardiography at laboratory for transthoracic echocardiography at the department of cardiology of Medical University Vienna will be enrolled following informed consent. Non-inclusion criteria are inability to understand study procedure and age under 18 years old. Patients with any grade of aortic regurgitation, congenital heart disease with intracardiac shunt (left-right shunt or right-left shunt) or arrhythmia (atrial fibrillation) or withdrawing consent during study procedure will be excluded. In addition, patients with intraabdominal (IAH), intracranial (ICH) hypertension or any disease of the hip joint, will not be included into the trial. |
| Right heart catheterisation | Other | Procedure: right heart catheterisationTwenty five patients undergoing routine right heart catheterization (RHC) at the department of cardiology for the evaluation of suspected pulmonary hypertension or heart failure will be included in this trial. EC measurements will be obtained during RHC, and a TTE (for measuring LVOT-area) will be performed immediately before undergoing RHC. Inclusion and exclusion criteria are similar as described above. |
| Passive leg raising test | Other | Other: passive leg raising test50 Patients undergoing routine transthoracic echocardiography at laboratory for transthoracic echocardiography at the department of cardiology of Medical University Vienna will be enrolled following informed consent. Non-inclusion criteria are inability to understand study procedure and age under 18 years old. Patients with any grade of aortic regurgitation, congenital heart disease with intracardiac shunt (left-right shunt or right-left shunt) or arrhythmia (atrial fibrillation) or withdrawing consent during study procedure will be excluded. In addition, patients with intraabdominal (IAH), intracranial (ICH) hypertension or any disease of the hip joint, will not be included into the trial. SV and CO will be measured using TTE and EC. Patient's legs will then be raised by 45degree, and SV and CO measurements will be repeated after 1 minute. Changes in SV and CO observed with both methods will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age above 18 years
- able to understand study procedure
Key exclusion criteria (4 listed)
- aortic regurgitation
- congenital heart disease with intracardiac shunt
- arrhythmia
- withdrawing consent
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 |
|---|---|---|
| passive leg raising testPatients undergoing routine echocardiography are exposed to a passive leg raising test. Change in SV will be measured by TTE and compared to changes in SV measured by EC. | Other | Passive leg raising test |
| right heart catheterisationCO in patients undergoing routine right heart catheterisation will be measured and compared between 3 methodologies: right heart catheterisation, TTE and EC | Procedure or surgery | Right heart catheterisation |
| TTE vs. EC + calibration groupPatients will undergo routine echocardiography. CO and SV will be measured by TTE and compared to measurements obtained from simultaneous EC-measurements. | Other | TTE vs. EC + calibration group |
Primary outcome
agreement Stroke volume
Time frame: 3 seconds
SV measured by TTE, RHC and EC will be compared
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing passive leg raising test, right heart catheterisation and TTE vs. EC + calibration group in people with Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Mar 2016. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clemens M Ortner, MD (+434040041009, clemens.ortner@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
agreement Stroke volume (time frame: 3 seconds). 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 8 Mar 2016.