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Completed

NCT Number: NCT03616613

Aortic Abdominal Aneurysm Pilot Screening Programme

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.

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Key information

Conditions

Aortic Aneurysm, Abdominal Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

65 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABDOMINAL DUPLEX ULTRASONOGRAPHY

Diagnostic Test

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

Primary outcomes

  1. Abdominal aortic measurement

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

    Ultrasound infrarrenal aortic diameter measurement in mm

Secondary outcomes

  1. Smoking habits

    Time frame: 1 day

    Defined by current smoker, former smoker (more than one year without smoking) or non smoker

  2. Surgical intervention if needed

    Time frame: 1 day

    Registry of kind of intervention and date of intervention

  3. Family AAA history

    Time frame: 1 day

    First or second degree relatives with AAA, or no family AAA history

  4. Personal Cardiovascular Risk Factors

    Time frame: 1 day

    Coronary disease, neurovascular disease, peripheral arterial disease or diabetes mellitus

  5. Dislipidaemia

    Time frame: 1 day

    Altered lipid parameters in blood analysis

  6. Arterial Hypertension

    Time frame: 1 day

    Arterial hypertension under medical treatment

  7. Height

    Time frame: 1 day

    measures in cm

  8. Weight

    Time frame: 1 day

    measures in kg

  9. Abdominal perimeter

    Time frame: 1 day

    measures in cm

  10. Goldberg questionnaire

    Time frame: 1 day

    Complete goldberg anxiety and depression questionnaire. It consists of 12 questions and 5 posible answers for each question, and each answer is rated with 1 to 5 points. Total score above 9 indicates risk of depression.

  11. EuroQOL 5 score

    Time frame: 1 day

    EuroQOL 5 quality of life evaluation questionnaire. It consistis of 5 questions with 3 posible answers for each question, and a visual analogical scale for self health perception. Each combination of answers indicates a pattern of health status that can be rated.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 6, 2018
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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