Genetics of Aortic Stenosis: From Family Forms to the Com... | NCT02890407

Studies
Genetics of Aortic Stenosis: From Family Forms to the Common Forms

NCT02890407

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Sep 7, 2016Estimated

Enrollment

1,987Actual

Phase

Not provided

Conditions

Aortic Stenosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Sep 1, 2016

First Submission Date that Met QC Criteria

Sep 6, 2016

First Posted Date

Sep 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The association study will compare the allele frequencies of polymorphisms of a single nucleotide (SNP) in the population of individuals with aortic stenosis compared to a control population.

Patients will be included only if they are suffering from a typical form of tight and surgical tricuspid aortic stenosis. Patients will therefore only included if they are suffering from aortic stenosis, the surface is less than 1 cm² and if histological analysis or failing intraoperative findings of the surgeon showed a tricuspid aortic stenosis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,987Actual

Measure	Description	Time Frame
identify the genetic factors involved in the occurrence of aortic stenosis		36 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Criteria has reached:
- That patients are operated or not, they can be considered as having a degenerative aortic stenosis, patients will be diagnosed with aortic stenosis (aortic area <1 cm) without obvious cause found.
criteria not met
- Strictly normal aortic valve by ultrasound in an over 65-year-old patient.
- All patients do not fit into the above two categories are considered as having an unknown phenotype and will not be used in binding assays. In particular, the presence of an aortic sclerosis or even moderate aortic regurgitation can be considered as potentially incipient form of aortic stenosis, patients with this type of anomaly will not be scanned during family analyzes.

Exclusion Criteria:

Patients who did not sign the consent
Non degenerative aortic stenosis or for which another cause could be found.

Among the most commonly found causes are:

Bicuspid aortic valve
Severe renal impairment
Severe Hypercholesterolemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Criteria has reached:
- That patients are operated or not, they can be considered as having a degenerative aortic stenosis, patients will be diagnosed with aortic stenosis (aortic area <1 cm) without obvious cause found.
criteria not met
- strictly normal aortic valve by ultrasound in an over 65-year-old patient.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU Angers		Angers			France
CHU de Nantes -

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35427703	Derived	Boureau AS, Karakachoff M, Le Scouarnec S, Capoulade R, Cueff C, de Decker L, Senage T, Verhoye JP, Baufreton C, Roussel JC, Dina C, Probst V, Schott JJ, Le Tourneau T. Heritability of aortic valve stenosis and bicuspid enrichment in families with aortic valve stenosis. Int J Cardiol. 2022 Jul 15;359:91-98. doi: 10.1016/j.ijcard.2022.04.022. Epub 2022 Apr 13.

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases