NCT01679288

Brief Summary

The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA) and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general practitioner in Primary Health Care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

June 26, 2012

Last Update Submit

October 15, 2014

Conditions

Keywords

Hand-Held ultrasonographyAbdominal Aortic AneurysmAbdominal Aortic AtherosclerosisCardiovascular riskPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.

    24 months

Secondary Outcomes (1)

  • Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care

    24 months

Study Arms (1)

ultrasound arm

EXPERIMENTAL

Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).

Device: Ultrasound (Trademark:VScan; Manufacturer:General Electrics)

Interventions

Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).

ultrasound arm

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokers
  • Former smokers.
  • Hypertensive patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAPSE

Barcelona, Barcelona, 08028, Spain

Location

Related Links

MeSH Terms

Conditions

HypertensionAortic Aneurysm, AbdominalAtherosclerosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAortic AneurysmAneurysmAortic DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Antoni Sisó Almirall, MD PhD

    Consorci d'Atenció Primària de Salut de l'Eixample

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

June 26, 2012

First Posted

September 6, 2012

Study Start

January 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations