Aortic Abdominal Aneurysm Pilot Screening Programme

August 3, 2018 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2194

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abdominal aortic measurement
Time Frame: Days (only one day measurement is performed)
Ultrasound infrarrenal aortic diameter measurement in mm
Days (only one day measurement is performed)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Smoking habits
Time Frame: 1 day
Defined by current smoker, former smoker (more than one year without smoking) or non smoker
1 day
Surgical intervention if needed
Time Frame: 1 day
Registry of kind of intervention and date of intervention
1 day
Family AAA history
Time Frame: 1 day
First or second degree relatives with AAA, or no family AAA history
1 day
Personal Cardiovascular Risk Factors
Time Frame: 1 day
Coronary disease, neurovascular disease, peripheral arterial disease or diabetes mellitus
1 day
Dislipidaemia
Time Frame: 1 day
Altered lipid parameters in blood analysis
1 day
Arterial Hypertension
Time Frame: 1 day
Arterial hypertension under medical treatment
1 day
Height
Time Frame: 1 day
measures in cm
1 day
Weight
Time Frame: 1 day
measures in kg
1 day
Abdominal perimeter
Time Frame: 1 day
measures in cm
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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