Aortic Abdominal Aneurysm Pilot Screening Programme

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616613
• Other study ID #: IIBSP-AAA-2017-42
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: August 2018
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2194
• Est. completion date: June 1, 2018
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: 65 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal aortic measurement	Ultrasound infrarrenal aortic diameter measurement in mm	Days (only one day measurement is performed)
Secondary	Smoking habits	Defined by current smoker, former smoker (more than one year without smoking) or non smoker	1 day
Secondary	Surgical intervention if needed	Registry of kind of intervention and date of intervention	1 day
Secondary	Family AAA history	First or second degree relatives with AAA, or no family AAA history	1 day
Secondary	Personal Cardiovascular Risk Factors	Coronary disease, neurovascular disease, peripheral arterial disease or diabetes mellitus	1 day
Secondary	Dislipidaemia	Altered lipid parameters in blood analysis	1 day
Secondary	Arterial Hypertension	Arterial hypertension under medical treatment	1 day
Secondary	Height	measures in cm	1 day
Secondary	Weight	measures in kg	1 day
Secondary	Abdominal perimeter	measures in cm	1 day
Secondary	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
Secondary	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