Valvular Aortic Stenosis Prognosis Study

NCT ID: NCT03628313

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2025-07-31

Brief Summary

Aortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is the reference method for assessment of aortic stenosis and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low flow and low gradient aortic retraction is discussed.

The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic retraction.

Detailed Description

Aortic stenosis is an attack most often acquired from the aortic valve corresponding to a defect of opening of this valve. Its prevalence increases with age and approaches 2% at age 65 and 25% at age 85 . It is in the majority of cases degenerative due to the development of calcifications on the aortic sigmoid valves by a process close to atherosclerosis (Otto CM, Circulation, 1994). It is associated with cardiovascular risk factors (age, male sex, smoking, high blood pressure and associated high LDL cholesterol). Aortic stenosis may also frequently be the consequence of aortic bicuspid (congenital) or more rarely rheumatic fever.

Aortic stenosis is responsible for an obstacle to ejection of the left ventricle with increased afterload and thus left ventricular work. After a long asymptomatic period when the obstacle to ejection is compensated by the induction of an adaptive left ventricular hypertrophy, symptoms appear initially of effort (dyspnea, angina, lipothymia see syncope) then clinical signs of insufficiency heart. The occurrence of symptoms should cause aortic valve replacement because at this stage the prognosis becomes unfavorable with a risk of death by cardiac decompensation or sudden death.

The two pillars of the diagnosis of severity are the evaluation of functional aortic valve area and the average transvalvular gradient. The tight aortic stenosis is defined for a functional aortic area <1cm² or 0.6cm² / m² and a mean tranvular gradient> 40 mmHg.

Patient survival data and / or a possible complication or indication for surgery will be evaluated periodically either during a standard follow-up consultation if patients are followed in the referral center or by telephone contact with the attending physician or cardiologist. . In case of death, the cause and date will be collected.

Conditions

Morality

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Aortic valve stenosis

The participants will be identified from the Transthoracic ultrasound echocardiography reports of the echocardiography laboratory of the University Hospital of Amiens and CH Philibert for the retrospective part. They are analyzed during echocardiography at the echocardiography laboratory of two participating centers when a diagnosis of aortic stenosis is made. Patients are informed by newsletter.

Transthoracic ultrasound

Intervention Type: OTHER

Patients are prospectively identified during echocardiography performed in the echocardiography laboratory of the two participating centers when a diagnosis of aortic stenosis is made.

Interventions

Transthoracic ultrasound

Patients are prospectively identified during echocardiography performed in the echocardiography laboratory of the two participating centers when a diagnosis of aortic stenosis is made.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Retrospectively, all patients examined from January 1, 2000 to November 2014 will be included in the echocardiography laboratory whose objective examination is a narrowing of the aortic valve (maximum transaortic velocity ≥2.5 m / s).
• Aortic stenosis may be known in the past.

Exclusion Criteria

• Refusal of the patient to participate in the study.
• Patients who have previously had aortic valve surgery before being examined in the echocardiography laboratory.
• Patients who can not be contacted or who do not respond will not be included in the database.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe TRIBOUILLOY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU AMIENS

Locations

Chu Amiens-Picardie

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christophe TRIBOUILLOY, MD, PhD

Role: CONTACT

Tribouilloy.Christophe@chu-amiens.fr

0322087251

Sylvestre MARECHAUX, MD, PhD

Role: CONTACT

sylvestre.marechaux@yahoo.fr

0320225050

Facility Contacts

TRIBOUILLOY CHRISTOPHE

Role: primary

Other Identifiers

RNI2014-16

Identifier Type: -

Identifier Source: org_study_id