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

Abdominal Aortic Aneurysm Clinical Trial

— DAAAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623268
• Other study ID #: DAAAD
• Status: Completed
• Start date: October 12, 2020
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2022
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: November 15, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Diagnostic Test:
• Ultrasound 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

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of registry-based detection model for screening.	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%.	One year after baseline
Other	Cost Effectiveness of program measured by quality-adjusted life-years	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.	One year after baseline
Primary	Prevalence of AAA	Ultrasound or CT 30 mm aortic diameter	baseline
Secondary	Awareness of hereditability and anxiety levels	Questionnaire based information	baseline