- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07577128
Familial Risk of AAA in Sweden
Familial Risk of Abdominal Aortic Aneurysm in Sweden
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Stockholm, Suecia
- Karolinska Institutet
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
-
Exclusion Criteria:
- younger than 45 years.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Familial risk of Abdominal Aortic Aneurysm in first-degree relatives compared with the population.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heredity as a risk factor for AAA
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Karolinska Institutet (Otro identificador: Karolinska Institutet)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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