Screening for Aortic Aneurysms in Inland Norway (NOR-AORTA)

May 13, 2025 updated by: Sykehuset Innlandet HF

Screening for Infra-renal Abdominal Aortic Aneurysms in 65-year-old Men in Inland, Norway

The number of AAA-surgeries performed per capita is 3-4 times higher in Innlandet county, as compared to Oslo. The last three years the annual incidence of AAA requiring treatment has been 21.5 / 100 000 inhabitants in Innlandet, as compared to 6.6 / 100 000 in Oslo. The indication for surgery is the same in both regions. In Oslo, a screening program was established in 2011, reporting a prevalence of AAA of 2.6 %, but in Innlandet county all AAA are either symptomatic or incidental findings and the prevalence is unknown. The aetiology of the major difference in AAA prevalence between these two regions has not been previously explored.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Abdominal aortic aneurysm (AAA) is a dilatation of the main artery from the heart as it passes through the abdomen. In case of rupture, the condition is life threatening and acute surgery is required. The prevalence of AAA is four to six times higher in men as compared to women, and varies greatly between countries and regions, but is generally reported to be present in 1.5-5% of men. Over the last three decades, the prevalence of AAA has been relatively stable, despite improved medical therapy for cardiovascular disease and a declining use of tobacco in Norway and comparable countries. This may in part be a consequence of unchanged aneurysmal progression rate combined with improved life expectancy of individuals at risk of developing AAA. Approximately 1% of all deaths in men over 65 years of age in Norway is caused by a ruptured AAA. The mortality is 75-80% after rupture, and half the patients die before they reach a hospital with vascular surgery. A patient with an incidental finding of AAA will be offered surgery in an elective setting to prevent rupture. The number of AAA surgeries in Norway was 851 in 2021 according to the Norwegian Vascular Surgery Registry (NORKAR).

The key challenge in improvement of aneurysm related mortality is to detect the disease while it is still asymptomatic. Screening is required to detect an asymptomatic AAA and is considered a beneficial healthcare intervention in several European countries.

We hypothesize that the prevalence of AAA is significantly higher in Innlandet, as compared to Oslo, and further, that the discrepancies in AAA prevalence between regions may be caused by differences in prevalence of risk factors, medication, socio-economic status, or in variations in genetic susceptibility.

Several genetic markers and other biomarkers have been proposed to relate to aneurysm disease. Of the clinically applicable biomarkers D-dimer, LDL cholesterol, HDL cholesterol, Thrombocytes, Apolipoprotein B and HbA1c have been found to have the most significant association to aneurysm growth rate. Studies on biomarkers for AAA have been hampered by low number of patients and currently no specific biomarker has been identified as a tool to identify patients with AAA or to predict aneurysm growth and studies on larger populations of patients with AAA have been called for.

The number of AAA-surgeries performed per capita is 3-4 times higher in Innlandet county, as compared to Oslo. The last three years the annual incidence of AAA requiring treatment has been 21.5 / 100 000 inhabitants in Innlandet, as compared to 6.6 / 100 000 in Oslo. The indication for surgery is the same in both regions. In Oslo, a screening program was established in 2011, reporting a prevalence of AAA of 2.6 %, but in Innlandet county all AAA are either symptomatic or incidental findings and the prevalence is unknown. The aetiology of the major difference in AAA prevalence between these two regions has not been previously explored.

There is some data on the psychological impact of a AAA screening and how a screening may impact the quality of life in patients diagnosed with AAA. However, there are still uncertainties towards the potential psychological harm of AAA screening, and further studies are required. Additionally, patients with AAA have in small studies an 80% reported prevalence of moderate to severe erectile dysfunction which is significantly higher than in the general population. Erectile dysfunction is also found to have an impact on the individual's quality of life, but the data on erectile dysfunction in AAA patients is limited.

Only men are included in the study. A prevalence of ≥1.5% is considered the cut-off for cost-benefit for screening for AAA. Previous studies have concluded that screening of women is not clinically indicated or cost-effective. Evaluation of recent data from the Norwegian Vascular Surgery registry has shown a stable proportion of women treated for AAA in Innlandet over several years. Consequently, women will not be incorporated into the study.

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Hamar, Norway
        • Sykehuset Innlandet

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

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All men in Innland Norway

Description

Inclusion Criteria:

  • All men in Inland Norway are invited

Exclusion Criteria:

  • unwilling or unable to concent

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
Patients with AAA
65-year old men in Inland, Norway will be invited by mail to a screening. Patients with detected aneurysm will be followed over time with blood samples and questionnaires in addition to ultrasound measurement of the diameter of the infrarenal abdominal aortic aneurysm.
Control group (no AAA)
65-year old men in Inland, Norway will be invited by mail to a screening. A matched group of individuals without AAA will be included as control patients and followed with blood samples and questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence
Time Frame: 3 years
Prevalence of AAA is examined by screening of all 65 year old men in Innland, Norway during a period of three years. Screening is performed by ultrasound measurement of AP outer-outer diameter.
3 years
Etiology
Time Frame: 3 years
Etiology of the anticipated high prevalence of AAA is explored through questionnaires and blood samples. Baseline charactereristics is to be compared to a different region in Norway with a similar screening project, and to be compared with control patients.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aneurysm related mortality
Time Frame: 6 years
The norwegian cause of death registry will be consulted to find aneurysm related mortality in the region before, during and after introduction of the screening program.
6 years
All cause mortality
Time Frame: 6 years
The norwegian cause of death registry will be consulted to find aneurysm related mortality and all cause mortality in the region before, during and after introduction of the screening program.
6 years
Prevalence of peripheral arterial insufficiency
Time Frame: 3 years
Ankle brachial index will be measured in all patients. Ankle brachial index is a the measure of systolic blood pressure in the arm compared to the systolic blood pressure at the ankle. A normal ABI is 0,9-1,2, ranging from 0-1,5 (over 1,5 = incompressible vessels)
3 years
Prevalence of erectile dysfunction
Time Frame: 3 years
Patients will be asked to fill out IIEF (erectile function questionnaire) to evaluate the prevalence and degree of erectile dysfunction in Inland Norway. 5 questions, each ranging from 1-5.
3 years
Quality of Life following screening
Time Frame: 6 years
Effect of screening on qol are measured with SF-36 at baseline, 6 months and one year. A score from 0-100 is obtained through the questionnaire.
6 years

Collaborators and Investigators

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

Sponsor

Sykehuset Innlandet HF

Investigators

  • Study Chair: Simen T Berge, MD PhD, Sykehuset Innlandet, UiO
  • Principal Investigator: Chrissie M Andersen, MD, Sykehuset Innlandet, UiO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 14, 2024

Primary Completion (Estimated)

May 9, 2027

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI-150503

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

product manufactured in and exported from the U.S.

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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