Cardiovascular PathologyLAXNCT01275963
New Echocardiographic Parameters for Assessment of Longitudinal Left Ventricular Function
An observational study of Cardiovascular Pathology, run by Heidelberg University at 1 site in Germany.
Trial summary
Assessment of left ventricular systolic function is the most frequent indication for routine echocardiography. Qualitative eyeball method and biplane modified Simpson's rule, both measuring radial ventricular function, are the currently recommended methods to meet this challenge. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Pathology
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Oct 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals and patients with various cardiac pathologies, who undergo routine echocardiography at our department
Who may be able to join
- persons of 18 years and older who receive a transthoracic echocardiography at our department
- written consent
Who cannot join
- permanent pacemaker rhythm
- moderate/severe valvular heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of left ventricular systolic function is the most frequent indication for routine echocardiography. Qualitative eyeball method and biplane modified Simpson's rule, both measuring radial ventricular function, are the currently recommended methods to meet this challenge. Due to the complexity of the myocardial architecture, global left ventricular function also has longitudinal and torsional components.
The aim of this study is to evaluate new echocardiographic parameters for longitudinal left ventricular function. A special focus is set on strain imaging by speckle tracking, which is a relatively new technique. Patients with different cardiac pathologies (e. g. dilated cardiomyopathy, coronary artery disease, diastolic dysfunction) will be included and compared to healthy individuals.
- Conditions
- Cardiovascular Pathology
- Keywords
- Echocardiography, Strain imaging, Ventricular Dysfunction, Cardiomyopathy, Longitudinal left ventricular function
- Medical subject headings
- Ventricular Dysfunction, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy individuals without structural heart disease | |
| CAD | Patients with coronary artery disease | |
| DCM | Participants with dilated cardiomyopathy | |
| HNCM | Patients with hypertrophic non-obstructive cardiomyopathy | |
| HOCM | Patients with hypertrophic obstructive cardiomyopathy | |
| RCM | Patients with restrictive cardiomyopathy | |
| Amyloidosis | Patients with cardiac manifestation of amyloidosis | |
| HFPEF | Patients with heart failure with preserved ejection fraction (diastolic heart failure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular longitudinal systolic strain (LV-LSS) in all patients
left ventricular longitudinal systolic strain (LV-LSS) is measured in all patients by speckle tracking strain imaging
Measured: 2 years
Secondary outcomes (5)
mitral annular plane systolic excursion (MAPSE) in all patients
MAPSE is measured by M-Mode echocardiography
Measured: 2 years
mitral annular systolic velocity (MASV) in all patients
MASV is derived from tissue doppler
Measured: 2 years
diastolic left ventricular function in all patients
Diastolic function is assesed by mitral inflow, mitral annulus velocity, pulmonary vein flow and velocity of flow progression.
Measured: 2 years
pulmonary artery systolic pressure (PASP) in all patients
PASP is derived from Tricuspid valve regurgitation velocity
Measured: 2 years
left ventricular ejection fraction (LVEF) in all patients
EF is measured by modified Simpson's rule (biplane)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2016
- Study completionOct 2016
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 Cardiovascular PathologyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derliz Mereles, Heidelberg University
- Investigators
- Matthias Aurich, M.D., Principal investigator, Heidelberg UniversityDerliz Mereles, M.D., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275963
- Sponsor's protocol ID
- S-401/2010
- Acronym
- LAX
- Status last verified
- Nov 2016
- First submitted
- 12 Jan 2011
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Aurich M, Keller M, Greiner S, Steen H, Aus dem Siepen F, Riffel J, Katus HA, Buss SJ, Mereles D. Left ventricular mechanics assessed by two-dimensional echocardiography and cardiac magnetic resonance imaging: comparison of high-resolution speckle tracking and feature tracking. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1370-1378. doi: 10.1093/ehjci/jew042. Epub 2016 Mar 24.
PubMed 27013249
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Echocardiographic Parameters for Assessment of Longitudinal Left Ventricular Function
- ClinicalTrials.gov ID
- NCT01275963
- Acronym / sponsor ID
- LAX / S-401/2010
- Conditions
- Cardiovascular Pathology
- Keywords
- Echocardiography, Strain imaging, Ventricular Dysfunction, Cardiomyopathy, Longitudinal left ventricular function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Jan 2011 (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.
Assessment of left ventricular systolic function is the most frequent indication for routine echocardiography. Qualitative eyeball method and biplane modified Simpson's rule, both measuring radial ventricular function, are the currently recommended methods to meet this challenge. Due to the complexity of the myocardial architecture, global left ventricular function also has longitudinal and torsional components.
The aim of this study is to evaluate new echocardiographic parameters for longitudinal left ventricular function. A special focus is set on strain imaging by speckle tracking, which is a relatively new technique. Patients with different cardiac pathologies (e. g. dilated cardiomyopathy, coronary artery disease, diastolic dysfunction) will be included and compared to healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy individuals without structural heart disease |
| CAD | – | –Patients with coronary artery disease |
| DCM | – | –Participants with dilated cardiomyopathy |
| HNCM | – | –Patients with hypertrophic non-obstructive cardiomyopathy |
| HOCM | – | –Patients with hypertrophic obstructive cardiomyopathy |
| RCM | – | –Patients with restrictive cardiomyopathy |
| Amyloidosis | – | –Patients with cardiac manifestation of amyloidosis |
| HFPEF | – | –Patients with heart failure with preserved ejection fraction (diastolic heart failure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals and patients with various cardiac pathologies, who undergo routine echocardiography at our department
Key inclusion criteria (2 listed)
- persons of 18 years and older who receive a transthoracic echocardiography at our department
- written consent
Key exclusion criteria (2 listed)
- permanent pacemaker rhythm
- moderate/severe valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
left ventricular longitudinal systolic strain (LV-LSS) in all patients
Time frame: 2 years
left ventricular longitudinal systolic strain (LV-LSS) is measured in all patients by speckle tracking strain imaging
5 secondary outcomes
mitral annular plane systolic excursion (MAPSE) in all patients
Time frame: 2 years
mitral annular systolic velocity (MASV) in all patients
Time frame: 2 years
diastolic left ventricular function in all patients
Time frame: 2 years
pulmonary artery systolic pressure (PASP) in all patients
Time frame: 2 years
left ventricular ejection fraction (LVEF) in all patients
Time frame: 2 years
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 8 Nov 2016.
- Derived from this study: PubMed 27013249Aurich M, Keller M, Greiner S, Steen H, Aus dem Siepen F, Riffel J, Katus HA, Buss SJ, Mereles D. Left ventricular mechanics assessed by two-dimensional echocardiography and cardiac magnetic resonance imaging: comparison of high-resolution speckle tracking and feature tracking. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1370-1378. doi: 10.1093/ehjci/jew042. Epub 2016 Mar 24.
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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.
Matthias Aurich, M.D. principal investigator
Heidelberg University
Derliz Mereles, M.D. principal investigator
Heidelberg University
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 Cardiovascular Pathology, run by Heidelberg 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 2 inclusion and 2 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 8 Nov 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 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?
left ventricular longitudinal systolic strain (LV-LSS) in all patients (time frame: 2 years). 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 NCT01275963, 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 8 Nov 2016.