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Detecting Abdominal Aortic Aneurysms in First Degree Relatives (Adult Offsprings) to AAA Patients (DAAAD)

Detecting Abdominal Aortic Aneurysms in First Degree Relatives (Adult Offsprings) to AAA Patients (DAAAD)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04623268
Acronym
DAAAD
Enrollment
1500
Registered
2020-11-10
Start date
2020-10-12
Completion date
2022-11-15
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

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.

Interventions

DIAGNOSTIC_TESTUltrasound and questionnaire

One invititation to identified adult offspring to have an ultrasound to detect an AAA. The prevalence in this Group (strata for sex) will be compared to a random selected matched Control group

Sponsors

Karolinska Institutet
CollaboratorOTHER
Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Not living in Stockholm below 45 or above 80

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of AAAbaselineUltrasound or CT 30 mm aortic diameter

Secondary

MeasureTime frameDescription
Awareness of hereditability and anxiety levelsbaselineQuestionnaire based information

Other

MeasureTime frameDescription
Feasibility of registry-based detection model for screening.One year after baselineComparison can be made with the screening program in men. The outcome here is to explore if it is possible to implement this register model nationally at reasonable cost and work load. Participation rates, detailed analysis of non-participants in the risk group vs control group. Screening models are measured as feasible if participation \>50%.
Cost Effectiveness of program measured by quality-adjusted life-yearsOne year after baselineQuality-adjusted life-years (QALYs) The prevalence in adult offspring, including cost of program, gives cost-effectiveness, probability of cost-effectiveness at different willingness-to-pay (WTP) thresholds, reduction in AAA death gained and total costs on a national scale. Presented as QUALY.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026