Aortic Valve StenosisNCT02608567
Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis
An observational study of Aortic Valve Stenosis and Asymptomatic Conditions, run by European Association of Cardiovascular Imaging at 1 site in France.
Trial summary
In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left ventricular (LV) ejection fraction is well known. Consequently, there is class I indication for surgery in these patients when LV ejection fraction <50%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Asymptomatic Conditions, Left Ventricular Function
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Dec 2017
- 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: Asymptomatic patients with at least moderate aortic stenosis (mean pressure gradient >25mmHg or aortic valve area <1.5cm²) and left ventricular ejection fraction >50%.
Who may be able to join
- studies selected in PubMed, Embase, Ovid, and Google Scholar, published between 2005 and 2015 without language restriction according to the following criteria: "aortic stenosis" AND "longitudinal strain"
Who cannot join
- Studies reporting global longitudinal strain derived from VVI and not speckle tracking analysis.
- Studies with cohort of patients with aortic valve replacement indication
Trial locations and contacts
1 site in 1 country.
About this study
In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left ventricular (LV) ejection fraction is well known. Consequently, there is class I indication for surgery in these patients when LV ejection fraction <50%. However, there is growing evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection is still preserved. In asymptomatic AS patients with LV ejection fraction >50%, a reduced LV global longitudinal strain, as assessed using speckle tracking imaging with transthoracic echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and thus, to improve the risk stratification, the management and the timing of surgery. Several mono-centric observational small studies recently reported results emphasizing the role of LV global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted and may provide meaningful data. The investigators hypothesized that LV global longitudinal strain is a determinant of outcome in asymptomatic patients with AS and preserved LV ejection fraction.
- Medical subject headings
- Aortic Valve Stenosis, Asymptomatic Diseases
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 |
|---|---|---|
| Preserved LV GLS | Patients will be compared according to the level of LV global longitudinal strain (GLS) as derived from transthoracic echocardiography and speckle tracking analysis. Two groups will be compared regarding outcome: preserved LV GLS vs. reduced LV GLS. The definition use for reduced LV GLS will be >-16%. An optimal threshold would also be calculated and derived from the pooled data. | |
| Reduced LV GLS | The definition use for reduced LV GLS will be >-16%. An optimal threshold would also be calculated and derived from the pooled data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined outcome of death and cardiovascular-related hospitalization (including aortic valve replacement)
Measured: up to 10 years
Secondary outcomes (1)
Combined outcome of death and cardiovascular-related hospitalization (without aortic valve replacement)
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Association of Cardiovascular Imaging
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julien Magne, European Association of Cardiovascular Imaging
- Investigators
- Erwan Donal, MD, PhD, Study chair, European Association of Cardiovascular Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608567
- Sponsor's protocol ID
- EACVI-001
- Status last verified
- Feb 2017
- First submitted
- 17 Nov 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis
- ClinicalTrials.gov ID
- NCT02608567
- Acronym / sponsor ID
- EACVI-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- European Association of Cardiovascular ImagingUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Nov 2015 (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.
In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left ventricular (LV) ejection fraction is well known. Consequently, there is class I indication for surgery in these patients when LV ejection fraction <50%. However, there is growing evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection is still preserved. In asymptomatic AS patients with LV ejection fraction >50%, a reduced LV global longitudinal strain, as assessed using speckle tracking imaging with transthoracic echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and thus, to improve the risk stratification, the management and the timing of surgery. Several mono-centric observational small studies recently reported results emphasizing the role of LV global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted and may provide meaningful data. The investigators hypothesized that LV global longitudinal strain is a determinant of outcome in asymptomatic patients with AS and preserved LV ejection fraction.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preserved LV GLS | – | –Patients will be compared according to the level of LV global longitudinal strain (GLS) as derived from transthoracic echocardiography and speckle tracking analysis. Two groups will be compared regarding outcome: preserved LV GLS vs. reduced LV GLS. The definition use for reduced LV GLS will be >-16%. An optimal threshold would also be calculated and derived from the pooled data. |
| Reduced LV GLS | – | –The definition use for reduced LV GLS will be >-16%. An optimal threshold would also be calculated and derived from the pooled data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic patients with at least moderate aortic stenosis (mean pressure gradient >25mmHg or aortic valve area <1.5cm²) and left ventricular ejection fraction >50%.
Key inclusion criteria (1 listed)
- studies selected in PubMed, Embase, Ovid, and Google Scholar, published between 2005 and 2015 without language restriction according to the following criteria: "aortic stenosis" AND "longitudinal strain"
Key exclusion criteria (2 listed)
- Studies reporting global longitudinal strain derived from VVI and not speckle tracking analysis.
- Studies with cohort of patients with aortic valve replacement indication
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
Combined outcome of death and cardiovascular-related hospitalization (including aortic valve replacement)
Time frame: up to 10 years
1 secondary outcome
Combined outcome of death and cardiovascular-related hospitalization (without aortic valve replacement)
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Erwan Donal, MD, PhD study chair
European Association of Cardiovascular Imaging
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 Aortic Valve Stenosis and Asymptomatic Conditions, run by European Association of Cardiovascular Imaging at 1 site in France.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Feb 2017. 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 France. 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?
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?
Combined outcome of death and cardiovascular-related hospitalization (including aortic valve replacement) (time frame: up to 10 years). 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 7 Feb 2017.