- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07577128
Familial Risk of AAA in Sweden
Familial Risk of Abdominal Aortic Aneurysm in Sweden
Studieoversikt
Status
Detaljert beskrivelse
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
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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Stockholm, Sverige
- Karolinska Institutet
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
-
Exclusion Criteria:
- younger than 45 years.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The Familial risk of Abdominal Aortic Aneurysm in first-degree relatives compared with the population.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Heredity as a risk factor for AAA
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Karolinska Institutet (Annen identifikator: Karolinska Institutet)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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