Clinical trial NCT06403423: Screening for Aortic Aneurysms in Inland Norway
Official title: Screening for Infra-renal Abdominal Aortic Aneurysms in 65-year-old Men in Inland, Norway
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Abdominal Aortic Aneurysm
Erectile Dysfunction
Quality of Life
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 240
Sex: MALE
Minimum age (years): 65
Maximum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All men in Innland Norway

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* All men in Inland Norway are invited

Exclusion Criteria:

* unwilling or unable to concent

Primary outcomes:
measure: Prevalence
timeFrame: 3 years
measure: Etiology
timeFrame: 3 years
Secondary outcomes:
measure: Aneurysm related mortality
timeFrame: 6 years
measure: All cause mortality
timeFrame: 6 years
measure: Prevalence of peripheral arterial insufficiency
timeFrame: 3 years
measure: Prevalence of erectile dysfunction
timeFrame: 3 years
measure: Quality of Life following screening
timeFrame: 6 years
Other outcomes:
Locations:
city: Hamar
country: Norway
facility: Sykehuset Innlandet
Study officials:
affiliation: Sykehuset Innlandet, UiO
name: Simen T Berge, MD PhD
role: STUDY_CHAIR
affiliation: Sykehuset Innlandet, UiO
name: Chrissie M Andersen, MD
role: PRINCIPAL_INVESTIGATOR
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