Clinical trial NCT04623268: Detecting Abdominal Aortic Aneurysms in First Degree Relatives (Adult Offsprings) to AAA Patients (DAAAD)
Official title: Detecting Abdominal Aortic Aneurysms in First Degree Relatives (Adult Offsprings) to AAA Patients (DAAAD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2020-11-10
Enrollment: 1500
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Random selection of Adult offspring to registered AAA parent (adult offspring) and adult offspring not having a AAA parent (Controls)

Brief summary: The 8-12 fold higher risk for sisters and brothers of patients with Abdominal Aortic Aneurysms (AAA) to develop AAA compared to persons in the population is well known in the scientific community. Recently the value of the screening program for siblings has been analyzed and is shown to be highly cost-efficient, similar to the population based screening of 65-year old men for AAA. Most importantly detection of siblings also adresses and includes women at risk. The adult offsprings to AAA patient would hypothetically bear the same risk of AAA as siblings. This has never been evaluated scientifically due to the practical difficulties in tracking the offspring and inviting them to screening at an age when they are at risk of AAA-disease. In Sweden, the unique multigeneration registry exists which could support such detection, with the possibility to track adult offspring to patients, and investigate the true contemporary prevalence in them.

The DAAAD project aims at investigating the prevalence in adult offspring parallel to developing a model for such a selective screening program

Detailed description: This project will evaluate four questions

1. Feasibility of study design; can we evaluate the prevalence of AAA by inviting and detecting risk groups in national registries ?
2. Point prevalence of AAA in a riskgroup of adult offspring to AAA patients as compared to a matched control group
3. Quality of Life in risk groups: measuring HADS, EQ-5D and questionnaire on heredity, including their awareness on their risk for AAA
4. Cost-effectiveness of such a national program based on prevalence and EQ-5D

This program will evaluate the risk for AAA in adult offspring and also evaluate a highly probable effective registry-based detection route. This could be more cost-efficient than any other AAA screening program, since the prevalence presumably is very high, and the registry-based route could be cheaper than nurse-based detection or incidental screening. The ultimate benefit of this program will be a crude reduction of sudden deaths from AAA for adult offspring to AAA patients, and this will be specifically impressive for the female relatives that are never subjected to any AAA-screening in our country.

Eligibility criteria: Inclusion Criteria:

Adult offspring to registered AAA parent (adult offspring) adult offspring not having a AAA parent (Controls)

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Exclusion Criteria:

Not living in Stockholm below 45 or above 80

Primary outcomes:
measure: Prevalence of AAA
timeFrame: baseline
Secondary outcomes:
measure: Awareness of hereditability and anxiety levels
timeFrame: baseline
Other outcomes:
measure: Feasibility of registry-based detection model for screening.
timeFrame: One year after baseline
measure: Cost Effectiveness of program measured by quality-adjusted life-years
timeFrame: One year after baseline
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Rebecka Rebecka, professor
role: PRINCIPAL_INVESTIGATOR
References: