Aortic Abdominal Aneurysm Pilot Screening Programme

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Diagnostic test: ABDOMINAL DUPLEX ULTRASONOGRAPHY

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.

• Study Type: Observational
• Enrollment (Actual): 2194

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 65 years (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Abdominal ultrasonography performed by both primary care doctors or vascular surgeons in Hospital de la Santa Creu i Sant Pau area
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; Abdominal ultrasonography performed by both primary care doctors or vascular surgeons in Hospital de la Santa Creu i Sant Pau area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal aortic measurement	Ultrasound infrarrenal aortic diameter measurement in mm	Days (only one day measurement is performed)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking habits	Defined by current smoker, former smoker (more than one year without smoking) or non smoker	1 day
Surgical intervention if needed	Registry of kind of intervention and date of intervention	1 day
Family AAA history	First or second degree relatives with AAA, or no family AAA history	1 day
Personal Cardiovascular Risk Factors	Coronary disease, neurovascular disease, peripheral arterial disease or diabetes mellitus	1 day
Dislipidaemia	Altered lipid parameters in blood analysis	1 day
Arterial Hypertension	Arterial hypertension under medical treatment	1 day
Height	measures in cm	1 day
Weight	measures in kg	1 day
Abdominal perimeter	measures in cm	1 day
Goldberg questionnaire	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.	1 day
EuroQOL 5 score	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.	1 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: IIBSP-AAA-2017-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No