Transthoracic EchocardiographyNCT04490538
Evaluation of Right Ventricular Systolic Function by TAPSE Parameter From Subcostal View
An observational study of Transthoracic Echocardiography, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 1 site in Czechia.
Trial summary
The purpose of this study is to validate a new echocardiographic parameter evaluating right ventricular function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthoracic Echocardiography
- What is being tested?
- Transthoracic echocardiography
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 27 Jul 2020to 31 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult intensive care unit patients.
Who may be able to join
- Inpatients
- All patients hospitalised in intensive care unit indicated for transthoracic echocardiography examination
Who cannot join
- Age <18 years
- Insufficient imaging quality of transthoracic echocardiography
- Refusal of echocardiographic examination by patient
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Hospital Usti nad Labem
Ústí nad Labem, 40113
Roman Skulec, MD, PhD, 00420777577497, skulec@email.cz
About this study
Official title: Echocardiographic Evaluation of Right Ventricular Systolic Function by TAPSE Parameter Measured From Subcostal View Using Anatomical M-mode - Validation Clinical Study
The purpose of this study is to validate a new echocardiographic parameter evaluating right ventricular function.
Read the detailed description
The key conventional echocardiographic parameter evaluating right ventricular systolic function is the tricuspid annular plane systolic excursion (TAPSE). It is measured in apical four chamber view by conventional M-mode imaging. Other echocardiographic parameters of right ventricular systolic function (Fractional Area Change; Tricuspid Lateral Annular Systolic Velocity; Right Ventricular Index of Myocardial Performance) are evaluated in apical four chamber view as well. However, this view might not be clearly visible in the clinical setting of critical illness and subcostal view is often preferred for its higher quality. Unfortunately, conventional M-mode can not be used for measurement in this view but anatomical M-mode imaging can. Therefore, the investigators decided to evaluate whether TAPSE measured in subcostal view by anatomical M-mode (sTAPSE) correlates with conventional TAPSE and whether reliably reflects systolic right ventricular function.
- Conditions
- Transthoracic Echocardiography
- Being tested
- Transthoracic echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDiagnostic test
Conventional transthoracic echocardiographic examination at the intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Critically ill patients hospitalised at the intensive care unit indicated to echocardiographic examination. Receives: Diagnostic Test: Transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of sTAPSE in prediction of right ventricular systolic dysfunction
sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.
Measured: During the intervention
Secondary outcomes (1)
Correlation of sTAPSE with conventional TAPSE
sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start27 Jul 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transthoracic EchocardiographyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Responsible party
- Principal investigator, Roman Skulec, Masaryk Hospital Usti nad Labem
- Investigators
- Roman Skulec, MD, PhD, Principal investigator, Masaryk Hospital Usti nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490538
- Sponsor's protocol ID
- 284/34
- Status last verified
- Aug 2020
- First submitted
- 19 Jul 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.
PubMed 25712077
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Evaluation of Right Ventricular Systolic Function by TAPSE Parameter Measured From Subcostal View Using Anatomical M-mode - Validation Clinical Study
- ClinicalTrials.gov ID
- NCT04490538
- Acronym / sponsor ID
- 284/34
- Conditions
- Transthoracic Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 29 Jul 2020 (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 this study is to validate a new echocardiographic parameter evaluating right ventricular function.
Detailed description
The key conventional echocardiographic parameter evaluating right ventricular systolic function is the tricuspid annular plane systolic excursion (TAPSE). It is measured in apical four chamber view by conventional M-mode imaging. Other echocardiographic parameters of right ventricular systolic function (Fractional Area Change; Tricuspid Lateral Annular Systolic Velocity; Right Ventricular Index of Myocardial Performance) are evaluated in apical four chamber view as well. However, this view might not be clearly visible in the clinical setting of critical illness and subcostal view is often preferred for its higher quality. Unfortunately, conventional M-mode can not be used for measurement in this view but anatomical M-mode imaging can. Therefore, the investigators decided to evaluate whether TAPSE measured in subcostal view by anatomical M-mode (sTAPSE) correlates with conventional TAPSE and whether reliably reflects systolic right ventricular function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Diagnostic Test: Transthoracic echocardiographyCritically ill patients hospitalised at the intensive care unit indicated to echocardiographic examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult intensive care unit patients.
Key inclusion criteria (2 listed)
- Inpatients
- All patients hospitalised in intensive care unit indicated for transthoracic echocardiography examination
Key exclusion criteria (3 listed)
- Age <18 years
- Insufficient imaging quality of transthoracic echocardiography
- Refusal of echocardiographic examination by patient
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 |
|---|---|---|
| Transthoracic echocardiographyConventional transthoracic echocardiographic examination at the intensive care unit. | Diagnostic test | Critically ill patients |
Primary outcome
Validity of sTAPSE in prediction of right ventricular systolic dysfunction
Time frame: During the intervention
sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.
1 secondary outcome
Correlation of sTAPSE with conventional TAPSE
Time frame: During the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Background: PubMed 25712077Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.
- Individual participant dataSharing planned: No
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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.
Roman Skulec, MD, PhD principal investigator
Masaryk Hospital Usti nad Labem
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 Transthoracic Echocardiography, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 1 site in Czechia.
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 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: status not confirmed, as of the sponsor's last update on 19 Aug 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 Czechia. 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 Roman Skulec, MD, PhD (00420777577497, skulec@email.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of sTAPSE in prediction of right ventricular systolic dysfunction (time frame: During the intervention). 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 NCT04490538, which also lists 1 linked publication.
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 19 Aug 2020; AzTrials last refreshed its copy on 1 Nov 2026.