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

Sponsor
Karolinska University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04623268
Collaborator
Karolinska Institutet (Other)
1,500
1
41.6
36.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound and questionnaire

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
Anticipated Enrollment :
1500 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Detecting Abdominal Aortic Aneurysms in First Degree Relatives (Adult Offsprings) to AAA Patients (DAAAD)
Actual Study Start Date :
Oct 12, 2020
Anticipated Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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

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

Outcome Measures

Primary Outcome Measures

  1. Prevalence of AAA [baseline]

    Ultrasound or CT 30 mm aortic diameter

Secondary Outcome Measures

  1. Awareness of hereditability and anxiety levels [baseline]

    Questionnaire based information

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 80 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska University Hospital Stockholm Sweden 17176

Sponsors and Collaborators

  • Karolinska University Hospital
  • Karolinska Institutet

Investigators

  • Principal Investigator: Rebecka Rebecka, professor, Karolinska Institutet

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Rebecka Hultgren, Professor, adjunct, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT04623268
Other Study ID Numbers:
  • DAAAD
First Posted:
Nov 10, 2020
Last Update Posted:
Nov 10, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2020