Secondary Manifestations of ARTerial diseases in the Young with a chronic condition

Secondary Manifestations of ARTerial diseases in the Young with a chronic condition - SMART-Youth

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56581

Enrollment

1350

Registered

2024-02-15

Start date

2024-08-20

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis cardiovascular disease

Interventions

None listed

Eligibility

Age

2 Years to 64 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for SMART-Youth consist of children aged 8 to 18 years with various chronic conditions recruited from the PROactive cohort. PROactive includes the following chronic conditions: cystic fibrosis, juvenile idiopathic arthritis, systemic autoimmune diseases, chronic kidney disease, primary immunodeficiency, autoinflammatory conditions, inflammatory bowel disease, and congenital heart disease, as well as children with unexplained medical symptoms. Children from the neonatal follow-up program for prematurity and fetal growth restriction are planned to be included in the PROactive cohort soon. Substudy SMART-CF: Inclusion criteria for this study consist of patients with CF, 18 years of age and older.

Exclusion criteria

Exclusion criteria: There are no exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Carotid Intima Media Thickness (cIMT) and Aortic pulse wave velocity (PWV) as preclinical atherosclerosis outcomes.	—

Secondary

Measure	Time frame
Secondary Objectives: - Establish the development of cIMT and PWV measurements over time in children with various chronic conditions. - Determine the relationship between dyslipidemia phenotypes and preclinical atherosclerosis in various chronic conditions. - Compare the effect of lifestyle-related cardiovascular risk factors on preclinical atherosclerosis in children with and without a chronic condition. - Develop a cardiovascular risk model to assess preclinical atherosclerosis in children at risk. - Determine associations between psychosocial functioning and cardiovascular risk factors in children with a chronic condition. The secondary parameters include: carotid artery distension using ultrasound, endothelial functioning using flow mediated dilation (FMD), inflammation using CRP levels, respiratory functioning assessed by forced expiratory volume in 1 second (FEV1) and intra-abdominal and subcutaneous fat measurements using ultrasound assessment. Besides this, lifestyle-related determinants including nutrition (Questionnaire Eetscore Adolescents) and physical exercise (Questionnaire PAQ-A/C) are determined by validated questionnaires. Substudy SMART-CF: - Determine the relationship between dyslipidemia phenotypes and preclinical atherosclerosis in adults with CF. - Determine the effect of lifestyle-related cardiovascular risk factors in adults with CF. - Determine the association between psychosocial functioning and cardiovascular risk factors in adults with CF. - Investigate the effect of CFTR modulators on preclinical atherosclerosis in adults with CFDetermine the relation between cardiovascular risk factors and fertility characteristics (ovarian reserve and menstrual cycle) in adult females with CF. - Determine the relation between cardiovascular risk factors, ovarian reserve markers (AMH) and reproductive outcomes in adult females with CF.	—

Measure

Time frame

Secondary Objectives: - Establish the development of cIMT and PWV measurements over time in children with various chronic conditions. - Determine the relationship between dyslipidemia phenotypes and preclinical atherosclerosis in various chronic conditions. - Compare the effect of lifestyle-related cardiovascular risk factors on preclinical atherosclerosis in children with and without a chronic condition. - Develop a cardiovascular risk model to assess preclinical atherosclerosis in children at risk. - Determine associations between psychosocial functioning and cardiovascular risk factors in children with a chronic condition. The secondary parameters include: carotid artery distension using ultrasound, endothelial functioning using flow mediated dilation (FMD), inflammation using CRP levels, respiratory functioning assessed by forced expiratory volume in 1 second (FEV1) and intra-abdominal and subcutaneous fat measurements using ultrasound assessment. Besides this, lifestyle-related determinants including nutrition (Questionnaire Eetscore Adolescents) and physical exercise (Questionnaire PAQ-A/C) are determined by validated questionnaires. Substudy SMART-CF: - Determine the relationship between dyslipidemia phenotypes and preclinical atherosclerosis in adults with CF. - Determine the effect of lifestyle-related cardiovascular risk factors in adults with CF. - Determine the association between psychosocial functioning and cardiovascular risk factors in adults with CF. - Investigate the effect of CFTR modulators on preclinical atherosclerosis in adults with CFDetermine the relation between cardiovascular risk factors and fertility characteristics (ovarian reserve and menstrual cycle) in adult females with CF. - Determine the relation between cardiovascular risk factors, ovarian reserve markers (AMH) and reproductive outcomes in adult females with CF.

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Countries

Netherlands

Outcome results