Abdominal AneurysmNCT07577128
Familial Risk of AAA in Sweden
An observational study of Abdominal Aneurysm and Aortic Aneurysm, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The aim is to study the prevalence of abdominal aortic aneurysm in first degree relatives and the risk to develop AAA in individuals with heredity for AAA compared with the population ( without heredity for AAA).The study i based on national registers in Sweden with high coverage and capacity of linkage between… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Abdominal Aneurysm, Aortic Aneurysm, Aortic Aneurysm Abdominal
- How many people
- 900,000 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to 31 Dec 2028
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with the diagnose AAA or the cause of death AAA in Sweden 2010-2024. The first-degree relatives have been identified through the Swedish multigeneration register and then a register based identifiaction if having AAA or not. All men and female over 45 years old are included.
Who may be able to join
- -
Who cannot join
- younger than 45 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Familial Risk of Abdominal Aortic Aneurysm in Sweden
The aim is to study the prevalence of abdominal aortic aneurysm in first degree relatives and the risk to develop AAA in individuals with heredity for AAA compared with the population ( without heredity for AAA).The study i based on national registers in Sweden with high coverage and capacity of linkage between different registers.
Read the detailed description
The study is designed as a retrospective, descriptive case-control population based national study. By using national registers, eligible patients diagnosed with AAA during the time period 2010-2024 will be identified, ( treated and untreated). The time period includes when screening was established in Sweden resulting in a large cohort of diagnosed men. Hence, individuals with diagnosed with AAA will be identified through registers at the National health and bord of welfare (Cause of death register, National patient register, Discharge register). Matched controls by sex, age (+/- 1 year), region and income (low,medium, high) will be identified in a ratio of x 4 from Statistic Sweden. These individuals will then be linked to the multigeneration register for identification of their first degree relatoves (FDR). In the finalstep, the FDR will be linked to NBHW register in order to evaluate if the individuals are diagnosed with AAA (rAAA or iAAA) or not. Socioeconomic data and comorbidity will also be collected for FDR, indexperson and matched controls.
Overall aim: To improve the understanding of the hereditary patterns for aortic disease, with specific consideration of regional differences and sex.
Hypothesis: An increased risk to develop any aortic disease will be detected in persons with one or more first-degree-relatives diagnosed with an aortic disease, which will remain although standard adjustments will be considered (age, sex, comorbidity,socioeconomic status).
Aims: 1)To describe the risk for female and male first-degree relatives (FDR) to female and male persons diagnosed with AAA (index persons) to develop a diagnosed AAA,compared to the population. 2) Identification of possible predictive associated risk factors (modifiable/non-modifiable, protective or negative) age, sex, region, other cardiovascular diseases,comorbidities, several FDRs, socioeconomic situation, multilevel aortic disease thatinfluences the hereditary risk.3)To describe the distribution of female and male first-degree relatives (FDR) to female and male persons diagnosed with AAA (index persons) to be diagnosed with a ruptured AAA rather than intact AAA, compared to the population.
- Keywords
- Abdominal aortic aneurysm, Heredity, Screening, Familial risk
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Index cases | Individuals with diagnosed abdominal aortic aneurysm during 2010- 2024 | |
| First-degree relatives to index cases | First- degree relatives to index cases with AAA. Siblings, Parents, Children identified through the Multigeneration register. | |
| Index controls | Control population to index cases based on sex, age, region and income. | |
| First-degree relatives of controls | First-degree relatives of the control population (index controls). Individuals without familial AAA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Familial risk of Abdominal Aortic Aneurysm in first-degree relatives compared with the population.
To describe the risk for female and male first-degree relatives (FDR) to female and male persons diagnosed with AAA (index persons) to develop a diagnosed AAA, compared to the population.
Measured: Through study completion, data spanning 1952 to 2024
Secondary outcomes (1)
Heredity as a risk factor for AAA
Hypothesis: Although factors as age, male sex and cardiovascular disease increases the risk for AAA, heredity will remain a risk factor for development of AAA after adjustment.
- Identification of possible predictive associated risk factors (modifiable/non- modifiable, protective or negative) age, sex, region, other cardiovascular diseases, comorbidities, several FDRs, socioeconomic situation, multilevel aortic disease that influences the hereditary risk.
Measured: At time of AAA diagnosis, cases diagnosed between 2010 and 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study startJan 2010
- Primary completionJun 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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
- 900,000 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Swedish Heart Lung Foundation
- Responsible party
- Principal investigator, Rebecka Hultgren, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577128
- Sponsor's protocol ID
- Karolinska Institutet
- Status last verified
- May 2026
- First submitted
- 15 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with external parties due to Swedish legislation on personal data protection (GDPR) and restrictions governing access to national health register data. Data will only be accessible to the research team named in the ethical approval
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Risk of Abdominal Aortic Aneurysm in Sweden
- ClinicalTrials.gov ID
- NCT07577128
- Acronym / sponsor ID
- Karolinska Institutet
- Keywords
- Abdominal aortic aneurysm, Heredity, Screening, Familial risk
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 900,000 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Swedish Heart Lung Foundation
- Study start
- Jan 2010 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 May 2026 (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 aim is to study the prevalence of abdominal aortic aneurysm in first degree relatives and the risk to develop AAA in individuals with heredity for AAA compared with the population ( without heredity for AAA).The study i based on national registers in Sweden with high coverage and capacity of linkage between different registers.
Detailed description
The study is designed as a retrospective, descriptive case-control population based national study. By using national registers, eligible patients diagnosed with AAA during the time period 2010-2024 will be identified, ( treated and untreated). The time period includes when screening was established in Sweden resulting in a large cohort of diagnosed men. Hence, individuals with diagnosed with AAA will be identified through registers at the National health and bord of welfare (Cause of death register, National patient register, Discharge register). Matched controls by sex, age (+/- 1 year), region and income (low,medium, high) will be identified in a ratio of x 4 from Statistic Sweden. These individuals will then be linked to the multigeneration register for identification of their first degree relatoves (FDR). In the finalstep, the FDR will be linked to NBHW register in order to evaluate if the individuals are diagnosed with AAA (rAAA or iAAA) or not. Socioeconomic data and comorbidity will also be collected for FDR, indexperson and matched controls.
Overall aim: To improve the understanding of the hereditary patterns for aortic disease, with specific consideration of regional differences and sex.
Hypothesis: An increased risk to develop any aortic disease will be detected in persons with one or more first-degree-relatives diagnosed with an aortic disease, which will remain although standard adjustments will be considered (age, sex, comorbidity,socioeconomic status).
Aims: 1)To describe the risk for female and male first-degree relatives (FDR) to female and male persons diagnosed with AAA (index persons) to develop a diagnosed AAA,compared to the population. 2) Identification of possible predictive associated risk factors (modifiable/non-modifiable, protective or negative) age, sex, region, other cardiovascular diseases,comorbidities, several FDRs, socioeconomic situation, multilevel aortic disease thatinfluences the hereditary risk.3)To describe the distribution of female and male first-degree relatives (FDR) to female and male persons diagnosed with AAA (index persons) to be diagnosed with a ruptured AAA rather than intact AAA, compared to the population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Index cases | – | –Individuals with diagnosed abdominal aortic aneurysm during 2010- 2024 |
| First-degree relatives to index cases | – | –First- degree relatives to index cases with AAA. Siblings, Parents, Children identified through the Multigeneration register. |
| Index controls | – | –Control population to index cases based on sex, age, region and income. |
| First-degree relatives of controls | – | –First-degree relatives of the control population (index controls). Individuals without familial AAA. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with the diagnose AAA or the cause of death AAA in Sweden 2010-2024. The first-degree relatives have been identified through the Swedish multigeneration register and then a register based identifiaction if having AAA or not. All men and female over 45 years old are included.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- younger than 45 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Familial risk of Abdominal Aortic Aneurysm in first-degree relatives compared with the population.
Time frame: Through study completion, data spanning 1952 to 2024
To describe the risk for female and male first-degree relatives (FDR) to female and male persons diagnosed with AAA (index persons) to develop a diagnosed AAA, compared to the population.
1 secondary outcome
Heredity as a risk factor for AAA
Time frame: At time of AAA diagnosis, cases diagnosed between 2010 and 2024.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with external parties due to Swedish legislation on personal data protection (GDPR) and restrictions governing access to national health register data. Data will only be accessible to the research team named in the ethical approval
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aneurysm and 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 1 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Familial risk of Abdominal Aortic Aneurysm in first-degree relatives compared with the population. (time frame: Through study completion, data spanning 1952 to 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.