- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07577128
Familial Risk of AAA in Sweden
Familial Risk of Abdominal Aortic Aneurysm in Sweden
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Stockholm, Sweden
- Karolinska Institutet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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Exclusion Criteria:
- younger than 45 years.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Index cases
Individuals with diagnosed abdominal aortic aneurysm during 2010- 2024
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First-degree relatives to index cases
First- degree relatives to index cases with AAA.
Siblings, Parents, Children identified through the Multigeneration register.
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Index controls
Control population to index cases based on sex, age, region and income.
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First-degree relatives of controls
First-degree relatives of the control population (index controls).
Individuals without familial AAA.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Through study completion, data spanning 1952 to 2024
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Heredity as a risk factor for AAA
Time Frame: At time of AAA diagnosis, cases diagnosed between 2010 and 2024.
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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. 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 that influences the hereditary risk. |
At time of AAA diagnosis, cases diagnosed between 2010 and 2024.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karolinska Institutet (Other Identifier: Karolinska Institutet)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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