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Impact of LDL-C Trajectories and Cumulative Burden on Coronary Artery Disease Risk in Familial Hypercholesterolemia

Impact of LDL-C Trajectories and Cumulative Burden on Coronary Artery Disease Risk in Familial Hypercholesterolemia: The J-FH BURDEN Study, 2010-2022 - The J-FH BURDEN Study, 2010-2022

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000058135
Enrollment
200000
Registered
2025-06-10
Start date
2024-07-17
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Familial Hypercholesterolemia

Interventions

None listed

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals with record linkage between medical claims data (including diagnoses such as hypertension, diabetes, and dyslipidemia, as well as prescriptions and procedures) and specific health checkup data, in whom at least one LDL-C measurement is available in the health checkup records between April 1, 2010, and March 31, 2022. LDL-C levels >=250 mg/dL (HeFH threshold) or >=370 mg/dL (HoFH threshold) recorded at least once during the study period Age between 40 and 75 years at the time of the first qualifying LDL-C record

Exclusion criteria

Exclusion criteria: Individuals with a documented history of coronary heart disease (CHD) at baseline or at the start of follow-up (excluded from the main cohort but retained in restricted cubic spline and sensitivity analyses). Individuals with implausible or erroneous LDL-C measurements (e.g., >=999 mg/dL).

Design outcomes

Primary

MeasureTime frame
Incidence of major adverse cardiovascular events (Modified MACE), defined as: - Non-fatal myocardial infarction - Non-fatal ischemic stroke - Coronary revascularization procedures including PCI and CABG

Secondary

MeasureTime frame
- Lipid-lowering medication patterns (e.g., statins, PCSK9 inhibitors) - Cardiovascular-related rehospitalization - Healthcare resource utilization (e.g., total hospital days, costs)

Countries

Japan

Contacts

Public ContactKeiko Goto

Juntendo University Clinical genetics

khirano@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026