Clinical Trial: Establishment of a registry to contribute to the prevention of cardiovascular events in pediatric patients with suspected or confirmed familial hypercholesterolemia and their families (Japan)

Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061103) titled 'Establishment of a registry to contribute to the prevention of cardiovascular events in pediatric patients with suspected or confirmed familial hypercholesterolemia and their families' on March 30.

Study Type: Observational

Primary Sponsor: Institute - Kagawa University

Condition: Condition - Familial Hypercholesterolemia Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - Clinical data, including genetic testing results and lipid profiles, of pediatric patients with confirmed or suspected familial hypercholesterolemia will be prospectively collected and followed as part of a registry study. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Among patients and children identified with elevated LDL-C through the Kagawa Prefecture pediatric lifestyle disease prevention screening program and other health checkups, as well as their family members, those who are diagnosed with or suspected of having familial hypercholesterolemia (FH) according to the most recent diagnostic criteria of the Japanese Atherosclerosis Society (JAS) guidelines for FH or pediatric FH will be evaluated. The fulfillment of the latest guideline criteria will be confirmed through interviews with the patients or children, or directly with their family members, as well as through clinical examination. Key exclusion criteria - Patients and children diagnosed with hyper LDL cholesterolemia other than familial hypercholesterolemia (FH), including secondary causes of elevated LDL-C, will be excluded. The diagnosis of secondary hyper LDL cholesterolemia will be based on the identification of underlying conditions such as diabetes mellitus, hypothyroidism, nephrotic syndrome, and cholestatic liver disease or medication-related causes (e.g., corticosteroids), assessed through blood tests and medication history. Target Size - 800

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 05 Month 27 Day Date of IRB - 2025 Year 05 Month 27 Day Anticipated trial start date - 2025 Year 11 Month 01 Day Last follow-up date - 2034 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069915

Disclaimer: Curated by HT Syndication.