NCT03616613

Brief Summary

Populational abdominal aortic aneurysm (AAA) pilot screening programme performed by duplex ultrasonography in population born in 1952 in health areas depending from Hospital de la Santa Creu i Sant Pau in Barcelona. Descriptive data analysis and cost-effectiveness study will be performed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,194

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

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, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

June 14, 2018

Last Update Submit

August 3, 2018

Conditions

Aortic Aneurysm, Abdominal

Outcome Measures

Primary Outcomes (1)

  • Abdominal aortic measurement

    Ultrasound infrarrenal aortic diameter measurement in mm

    Days (only one day measurement is performed)

Secondary Outcomes (11)

  • Smoking habits

    1 day

  • Surgical intervention if needed

    1 day

  • Family AAA history

    1 day

  • Personal Cardiovascular Risk Factors

    1 day

  • Dislipidaemia

    1 day

  • +6 more secondary outcomes

Study Arms (2)

Men

Men born in 1952 in Barcelona in health areas depending from Hospital de la Santa Creu i Sant Pau.

Diagnostic Test: ABDOMINAL DUPLEX ULTRASONOGRAPHY

Women

Aleatory sample of women born in 1952 in Barcelona in health areas depending from Hospital de la Santa Creu i Sant Pau.

Diagnostic Test: ABDOMINAL DUPLEX ULTRASONOGRAPHY

Interventions

ABDOMINAL DUPLEX ULTRASONOGRAPHYDIAGNOSTIC_TEST

Abdominal ultrasonography performed by both primary care doctors or vascular surgeons in Hospital de la Santa Creu i Sant Pau area

MenWomen

Eligibility Criteria

Age65 Years - 65 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

All men and a random sample of women born in 1952 in Barcelona in the area that depends from Hospital de la Santa Creu i Sant Pau.

You may qualify if:

  • All men in our area's population census and an aleatory sample of women born in 1952 living in Hospital de la Santa Creu i Sant Pau area.

You may not qualify if:

  • Previously detected or operated AAA
  • Fragile patients not eligible for AAA repair if needed
  • Dead people when contacted
  • Eligible people refusing to participate
  • Eligible people failed to be contacted twice by our department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2018

First Posted

August 6, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2017

Study Completion

June 1, 2018

Last Updated

August 6, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share