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Completed

NCT Number: NCT04623268

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

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

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

This project will evaluate four questions

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound and questionnaire

Diagnostic Test

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

Primary outcomes

  1. Prevalence of AAA

    Time frame: baseline

    Ultrasound or CT 30 mm aortic diameter

Secondary outcomes

  1. Awareness of hereditability and anxiety levels

    Time frame: baseline

    Questionnaire based information

Other outcomes

  1. Feasibility of registry-based detection model for screening.

    Time frame: One year after baseline

    Comparison 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%.

  2. Cost Effectiveness of program measured by quality-adjusted life-years

    Time frame: One year after baseline

    Quality-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.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Acronym: DAAAD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2020
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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