Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403423
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-07
First Post:
2024-04-26
Brief Title:
Screening for Aortic Aneurysms in Inland Norway
Sponsor:
Sykehuset Innlandet HF
Organization:
Sykehuset Innlandet HF
Study Overview
Official Title:
Screening for Infra-renal Abdominal Aortic Aneurysms in 65-year-old Men in Inland Norway
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOR-AORTA
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 215 100 000 inhabitants in Innlandet as compared to 66 100 000 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 26 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 15-5 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 215 100 000 inhabitants in Innlandet as compared to 66 100 000 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 26 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 individuals quality of life but the data on erectile dysfunction in AAA patients is limited
Only men are included in the study A prevalence of 15 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
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 215 100 000 inhabitants in Innlandet as compared to 66 100 000 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 26 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 individuals quality of life but the data on erectile dysfunction in AAA patients is limited
Only men are included in the study A prevalence of 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None