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

NCT02608567 | Unknown

• 1 other identifier: EACVI-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis; Asymptomatic Conditions; Left Ventricular Function

Outcome Measures

Primary Outcomes (1)

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

  up to 10 years

Secondary Outcomes (1)

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

  up to 10 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%.

You may qualify if:

• 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"

You may not qualify if:

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

Sponsors & Collaborators

• European Association of Cardiovascular Imaging: lead

Study Sites (1)

CHU LImoges

Limoges, 87000, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erwan Donal, MD, PhD

  European Association of Cardiovascular Imaging

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EACVI board member - Research&Innovation committee member

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 18, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

FR (1)