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Clinical Trials/NCT03616613
NCT03616613
Completed
Not Applicable

Analysis of Aortic Abdominal Aneurysm Prevalence in a Population Pilot Screening Program Based on Primary Care Duplex Ultrasound Evaluation

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau0 sites2,194 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Aneurysm, Abdominal
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
2194
Primary Endpoint
Abdominal aortic measurement
Status
Completed
Last Updated
7 years ago

Overview

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.

Detailed Description

Populational abdominal aortic aneurysm (AAA) pilot screening programme performed by duplex ultrasonography in population born in 1952 in areas depending from Hospital de la Santa Creu i Sant Pau in Barcelona. Ultrasonography evaluations will be performed in primary health centers by previously trained doctors according to study protocol and AAA management will be according to United Kingdom's National Health Service screening model. A descriptive analysis will be performed to estimate local population prevalence of AAA in both men and women in order to create the basis for a future state AAA screening programme. A cost-effectiveness analysis will be performed in order to assess optimal screening strategies in our population.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
June 1, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Abdominal aortic measurement

Time Frame: Days (only one day measurement is performed)

Ultrasound infrarrenal aortic diameter measurement in mm

Secondary Outcomes

  • Family AAA history(1 day)
  • Smoking habits(1 day)
  • Surgical intervention if needed(1 day)
  • Personal Cardiovascular Risk Factors(1 day)
  • Weight(1 day)
  • Abdominal perimeter(1 day)
  • Goldberg questionnaire(1 day)
  • EuroQOL 5 score(1 day)
  • Dislipidaemia(1 day)
  • Arterial Hypertension(1 day)
  • Height(1 day)

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