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

NCT ID: NCT04623268

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2022-11-15

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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adult offspring

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

Ultrasound and questionnaire

Intervention Type: 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

Control group

Matched women and men, without parents with AAA. Matched in the Swedish Multigeneration registry

Ultrasound and questionnaire

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rebecka Hultgren

Professor, adjunct

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecka Rebecka, professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

References

Fattahi N, Linne A, Roy J, Stenman M, Svensjo S, Nilsson O, Hultgren R. Prevalence of abdominal aortic aneurysm (AAA) in first-degree relatives: detecting AAA in adult offspring of AAA patients. BJS Open. 2024 Jan 3;8(1):zrad163. doi: 10.1093/bjsopen/zrad163.

Reference Type: DERIVED

PMID: 38195162 (View on PubMed)

Hultgren R, Fattahi N, Nilsson O, Svensjo S, Roy J, Linne A. Evaluating feasibility of using national registries for identification, invitation, and ultrasound examination of persons with hereditary risk for aneurysm disease-detecting abdominal aortic aneurysms in first degree relatives (adult offspring) to AAA patients (DAAAD). Pilot Feasibility Stud. 2022 Dec 12;8(1):252. doi: 10.1186/s40814-022-01196-9.

Reference Type: DERIVED

PMID: 36503690 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

DAAAD

Identifier Type: -

Identifier Source: org_study_id