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Clinical Trials/NCT04623268
NCT04623268CompletedNot Applicable

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

Karolinska University Hospital1 site in 1 country1,500 target enrollmentStarted: October 12, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,500
Locations
1
Primary Endpoint
Prevalence of AAA

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
45 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Prevalence of AAA

Time Frame: baseline

Ultrasound or CT 30 mm aortic diameter

Secondary Outcomes

  • Awareness of hereditability and anxiety levels(baseline)

Investigators

Sponsor
Karolinska University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rebecka Hultgren

Professor, adjunct

Karolinska University Hospital

Study Sites (1)

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