- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07577128
Familial Risk of AAA in Sweden
Familial Risk of Abdominal Aortic Aneurysm in Sweden
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
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Stockholm, Zweden
- Karolinska Institutet
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
-
Exclusion Criteria:
- younger than 45 years.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The Familial risk of Abdominal Aortic Aneurysm in first-degree relatives compared with the population.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Heredity as a risk factor for AAA
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Karolinska Institutet (Andere identificatie: Karolinska Institutet)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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