Observatory of Screening Aneurysms of the Abdominal Aorta... | NCT01390740

Studies
Observatory of Screening Aneurysms of the Abdominal Aorta During Echocardiography. National Epidemiological Survey

NCT01390740

Sponsor

French Cardiology Society

Status

Completed

Last Update Posted

Aug 14, 2019Actual

Enrollment

1,412Actual

Phase

Not provided

Conditions

Abdominal Aortic Aneurysms

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

Aug 2019

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

May 2011Actual

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jul 7, 2011

First Submission Date that Met QC Criteria

Jul 8, 2011

First Posted Date

Jul 11, 2011Estimated

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

Aug 13, 2019

Last Update Posted Date

Aug 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Study of the prevalence of Abdominal Aortic Aneurysms (AAA) (> 3 cm) in patients with echocardiography (transthoracic or) during a specific day, with cardiologists in France.

This is a cross-sectional epidemiological investigation, assembling evidence from a routine ultrasound screening for AAA at the waning of echocardiograms performed during a specific day.

The study will be offered a list of centers selected by the Scientific Committee in the complete list of locations being in France, the subsidiary of echocardiography Echocardiography of French Society of Cardiology. These centers will be 500 in number representative of the French centers, geographically and by type of centers.

Detailed Description

Multicenter observational study collecting data from a routine ultrasound screening for AAA at the waning of echocardiograms performed during a specific day. All of the cardiologists practicing echocardiography are invited to participate in this study, each cardiologist should include echocardiography in 10 patients examined for any reason and will be considered referring cardiologist.

There will be no follow-up, the idea is to have a database with measures of abdominal aortic aneurysms and therefore.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

1,412Actual

Label	Type	Description	Intervention Names
Echocardiography		patients with echocardiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of patients with AAA among those with echocardiography.	Discovery of the aneurysm of the abdominal aorta at the waning of echocardiography	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient > 65 years,
Have an echocardiogram, whatever the reason,
Having agreed to participate in the study.

Exclusion Criteria:

Patients already operated in the aorta (AAA, PAD, stent, ...)
Patient refusal to participate in the study

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

The study proposed a list of centers selected by the Scientific Committee in the complete list of locations being in France, the subsidiary of echocardiography Echocardiography of the French Society of Cardiology. These centers number 500 are representative of the French centers, geographically and by type of centers.

This is a cross-sectional epidemiological investigation, assembling evidence from a routine ultrasound screening for AAA at the waning of echocardiograms performed during a specific day

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Office of Cardiology Kownator		Thionville			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10065509	Background	Jaussi A, Fontana P, Mueller XM. Imaging of the abdominal aorta during examination of patients referred for transthoracic echocardiography. Schweiz Med Wochenschr. 1999 Jan 23;129(3):71-6.
14715323	Background	Kertai MD, Boersma E, Westerhout CM, van Domburg R, Klein J, Bax JJ, van Urk H, Poldermans D. Association between long-term statin use and mortality after successful abdominal aortic aneurysm surgery. Am J Med. 2004 Jan 15;116(2):96-103. doi: 10.1016/j.amjmed.2003.08.029.

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases