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

Completed

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Diagnostic Test: Ultrasound and questionnaire

• Registration Number: NCT04623268
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study First Submitted: 2020-10-02
• Study Start: 2020-10-12
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-10
• Primary Completion: 2022-10-01
• Status Verified: 2022-11
• Study Completion: 2022-11-15
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult offspring	Ultrasound and questionnaire	Adult female and male offspring to AAA patients 45-80 years of age at inclusion Children to detected AAA patients. Found in the Multigeneration registry
Control group	Ultrasound and questionnaire	Matched women and men, without parents with AAA. Matched in the Swedish Multigeneration registry

Primary Outcome Measures

Name	Time	Method
Prevalence of AAA	baseline	Ultrasound or CT 30 mm aortic diameter

Secondary Outcome Measures

Name	Time	Method
Awareness of hereditability and anxiety levels	baseline	Questionnaire based information

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden