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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608567
Recruitment Status : Unknown
Verified February 2017 by Julien Magne, European Association of Cardiovascular Imaging.
Recruitment status was:  Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Julien Magne, European Association of Cardiovascular Imaging

Brief 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.

Condition or disease
Aortic Valve Stenosis Asymptomatic Conditions Left Ventricular Function

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis
Study Start Date : October 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Combined outcome of death and cardiovascular-related hospitalization (including aortic valve replacement) [ Time Frame: up to 10 years ]

Secondary Outcome Measures :
  1. Combined outcome of death and cardiovascular-related hospitalization (without aortic valve replacement) [ Time Frame: up to 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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%.
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608567


Locations
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France
CHU LImoges
Limoges, France, 87000
Sponsors and Collaborators
European Association of Cardiovascular Imaging
Investigators
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Study Chair: Erwan Donal, MD, PhD European Association of Cardiovascular Imaging

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Responsible Party: Julien Magne, EACVI board member - Research&Innovation committee member, European Association of Cardiovascular Imaging
ClinicalTrials.gov Identifier: NCT02608567    
Other Study ID Numbers: EACVI-001
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Asymptomatic Diseases
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Disease Attributes
Pathologic Processes