An observational study in Abdominal Aortic Aneurysm, Erectile Dysfunction and Quality of Life, sponsored by Sykehuset Innlandet HF. Enrolling by invitation at 1 site in Norway. Open to male participants aged 65 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Sykehuset Innlandet HF · Observational
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.
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.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 240 is above the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Sykehuset Innlandet HF is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
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All men in Innland Norway
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Exclusion Criteria:
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.
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.
Prevalence
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.
Time frame: 3 years
Etiology
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.
Time frame: 3 years
Aneurysm related mortality
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.
Time frame: 6 years
All cause mortality
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.
Time frame: 6 years
Prevalence of peripheral arterial insufficiency
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)
Time frame: 3 years
Prevalence of erectile dysfunction
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.
Time frame: 3 years
Quality of Life following screening
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.
Time frame: 6 years
Plan to share: No
Started May 2024 (actual). Primary completion is estimated for May 2027, 35 months after the start.
Of 67 non-industry observational studies under Aortic Aneurysm, Abdominal, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's planned 35 months is below that.
Counting every sponsor, half of 91 studies reached it within 48 months; a quarter within 24 and three quarters within 83.
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Sykehuset Innlandet HF