CClinicalTrials.gg
Status unknownNCT02608567Updated Feb 7, 2017

Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis

An observational study in Aortic Valve Stenosis, Asymptomatic Conditions and Left Ventricular Function, sponsored by European Association of Cardiovascular Imaging. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-07.

Sponsored by European Association of Cardiovascular Imaging · Observational

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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%. 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.

02

Conditions studied

  • Aortic Valve Stenosis
  • Asymptomatic Conditions
  • Left Ventricular Function
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 1,000 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

This is the only study on the registry with European Association of Cardiovascular Imaging as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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%.

Inclusion criteria

  • 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"

Exclusion criteria

Exclusion Criteria:

  • Studies reporting global longitudinal strain derived from VVI and not speckle tracking analysis.
  • Studies with cohort of patients with aortic valve replacement indication
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
1,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Combined outcome of death and cardiovascular-related hospitalization (including aortic valve replacement)

    Time frame: up to 10 years

Secondary outcomes

  1. Combined outcome of death and cardiovascular-related hospitalization (without aortic valve replacement)

    Time frame: up to 10 years

07

Study locations

1 site
  • CHU LImoges
    Limoges, 87000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02608567
Lead sponsor
European Association of Cardiovascular Imaging
Responsible party
Julien Magne (EACVI board member - Research&Innovation committee member, European Association of Cardiovascular Imaging) — Principal investigator
First posted
Nov 18, 2015
Start date
Oct 2015
Primary completion
Dec 2016
Completion
Dec 2017 (estimated)
Last update
Feb 7, 2017

Study contacts

Erwan Donal, MD, PhD
study chair · European Association of Cardiovascular Imaging

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion