Clinical Trials Directory

Trials / Completed

CompletedNCT04623268

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,500 (actual)
Sponsor
Karolinska University Hospital · Academic / Other
Sex
All
Age
45 Years – 80 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTUltrasound and questionnaireOne 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

Timeline

Start date
2020-10-12
Primary completion
2022-10-01
Completion
2022-11-15
First posted
2020-11-10
Last updated
2022-12-01

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT04623268. Inclusion in this directory is not an endorsement.