NCT04623268

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

October 12, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

October 2, 2020

Last Update Submit

November 30, 2022

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Prevalence of AAA

    Ultrasound or CT 30 mm aortic diameter

    baseline

Secondary Outcomes (1)

  • Awareness of hereditability and anxiety levels

    baseline

Other Outcomes (2)

  • Feasibility of registry-based detection model for screening.

    One year after baseline

  • Cost Effectiveness of program measured by quality-adjusted life-years

    One year after baseline

Study Arms (2)

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

Diagnostic Test: Ultrasound and questionnaire

Control group

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

Diagnostic Test: Ultrasound and questionnaire

Interventions

Ultrasound and questionnaireDIAGNOSTIC_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

Adult offspringControl group

Eligibility Criteria

Age45 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsStratified analysis
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Random selection of Adult offspring to registered AAA parent (adult offspring) and adult offspring not having a AAA parent (Controls)

You may qualify if:

  • Adult offspring to registered AAA parent (adult offspring) adult offspring not having a AAA parent (Controls)

You may not qualify if:

  • Not living in Stockholm below 45 or above 80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 38195162DERIVED

  • 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.

    PMID: 36503690DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Rebecka Rebecka, professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, adjunct

Study Record Dates

First Submitted

October 2, 2020

First Posted

November 10, 2020

Study Start

October 12, 2020

Primary Completion

October 1, 2022

Study Completion

November 15, 2022

Last Updated

December 1, 2022

Record last verified: 2022-11

Locations

SE(1)