Abdominal Aortic AneurysmDAAADNCT04623268
Detecting Abdominal Aortic Aneurysms in First Degree Relatives (Adult Offsprings) to AAA Patients (DAAAD)
An observational study of Abdominal Aortic Aneurysm, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Ultrasound and questionnaire
- How many people
- 1,500 participants
- Where
- 1 siteSweden
- Study dates
- 12 Oct 2020to 15 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Random selection of Adult offspring to registered AAA parent (adult offspring) and adult offspring not having a AAA parent (Controls)
Who may be able to join
- Adult offspring to registered AAA parent (adult offspring) adult offspring not having a AAA parent (Controls)
- -
Who cannot join
- Not living in Stockholm below 45 or above 80
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
This project will evaluate four questions
- Feasibility of study design; can we evaluate the prevalence of AAA by inviting and detecting risk groups in national registries ?
- Point prevalence of AAA in a riskgroup of adult offspring to AAA patients as compared to a matched control group
- Quality of Life in risk groups: measuring HADS, EQ-5D and questionnaire on heredity, including their awareness on their risk for AAA
- 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
- Being tested
- Ultrasound and questionnaire
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Ultrasound and questionnaire | |
| Control group | Matched women and men, without parents with AAA. Matched in the Swedish Multigeneration registry Receives: Diagnostic Test: Ultrasound and questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of AAA
Ultrasound or CT 30 mm aortic diameter
Measured: baseline
Secondary outcomes (1)
Awareness of hereditability and anxiety levels
Questionnaire based information
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start12 Oct 2020
- Primary completion1 Oct 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Rebecka Hultgren, Karolinska University Hospital
- Investigators
- Rebecka Rebecka, professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623268
- Sponsor's protocol ID
- DAAAD
- Acronym
- DAAAD
- Status last verified
- Nov 2022
- First submitted
- 2 Oct 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cannot share with patients' ID due to Ethic board regulation
Publications
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.
PubMed 38195162Hultgren 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.
PubMed 36503690
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Abdominal Aortic Aneurysms in First Degree Relatives (Adult Offsprings) to AAA Patients (DAAAD)
- ClinicalTrials.gov ID
- NCT04623268
- Acronym / sponsor ID
- DAAAD / DAAAD
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Feasibility of study design; can we evaluate the prevalence of AAA by inviting and detecting risk groups in national registries ?
- Point prevalence of AAA in a riskgroup of adult offspring to AAA patients as compared to a matched control group
- Quality of Life in risk groups: measuring HADS, EQ-5D and questionnaire on heredity, including their awareness on their risk for AAA
- 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult offspring | – | Diagnostic Test: Ultrasound and questionnaireAdult female and male offspring to AAA patients 45-80 years of age at inclusion Children to detected AAA patients. Found in the Multigeneration registry |
| Control group | – | Diagnostic Test: Ultrasound and questionnaireMatched women and men, without parents with AAA. Matched in the Swedish Multigeneration registry |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Random selection of Adult offspring to registered AAA parent (adult offspring) and adult offspring not having a AAA parent (Controls)
Key inclusion criteria (2 listed)
- Adult offspring to registered AAA parent (adult offspring) adult offspring not having a AAA parent (Controls)
- -
Key exclusion criteria (1 listed)
- Not living in Stockholm below 45 or above 80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound and questionnaireOne 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 | Diagnostic test | Adult offspring, Control group |
Primary outcome
Prevalence of AAA
Time frame: baseline
Ultrasound or CT 30 mm aortic diameter
1 secondary outcome
Awareness of hereditability and anxiety levels
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Derived from this study: PubMed 38195162Fattahi 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.
- Derived from this study: PubMed 36503690Hultgren 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.
- Individual participant dataSharing planned: Undecided. Cannot share with patients' ID due to Ethic board regulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecka Rebecka, professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of AAA (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04623268, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.