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NCT04958629 Clinical Trial

A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population

Familial Hypercholesterolemia Clinical Trial

Official title:
A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04958629
Other study ID # M2021098
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date December 31, 2023

Study information
Verified date June 2021
Source Peking University Third Hospital
Contact Wei Gao, Doctor
Phone +86 13901366179
Email weigao@bjmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To determine the prevalence and the prognosis in a corhort of patients with familial hypercholesterolemia (FH).

Description:

This study aims to achieve the following goals through prospective cohort study and statistical analysis: (1) to determine the prevalence of familial hypercholesterolemia (FH) in healthy people with hypercholesterolemia.（2) Compared with non FH population, the relative risk of atherosclerotic cardiovascular disease (ASCVD) in FH patients in China was calculated, and the risk prediction model of ASCVD in FH patients was constructed by using biochemical results, imaging data, biomarkers and other indicators.（3) To evaluate the benefits of different lipid-lowering strategies for FH patients in China.（4) To analyze the gene carriers of FH patients in China.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 318
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1) Patients with definite diagnosis of hyperlipidemia. Exclusion Criteria: 1. Age < 18. 2. Do not agree to participate in this study. 3. secondary hypercholesterolemia. 4. Phytosteronemia.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• familial hypercholesterolemia
Among the selected patients with hyperlipidemia, those who met the diagnostic criteria of FH were included in the study cohort as FH group.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Peking University Third Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with atherosclerotic cardiovascular disease (ASCVD) events 1) Fatal or non-fatal myocardial infarction; 2) Fatal or non-fatal ischemic stroke; 3) Coronary artery revascularization; 4) Peripheral artery revascularization; 5) Cardiogenic death 2 years from enrollmet
See also
  Status Clinical Trial Phase
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Completed NCT02750527 - Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
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Withdrawn NCT00751608 - Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients Phase 2
Terminated NCT00079846 - Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy Phase 2
Completed NCT02624869 - Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia) Phase 3
Recruiting NCT05758779 - The Danish Familial Hypercholesterolemia Organized Coronary Screening Trial N/A
Enrolling by invitation NCT04929457 - Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia
Not yet recruiting NCT04455581 - A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia Phase 2
Recruiting NCT04101149 - Genetic Causes of Familial Hypercholesterolemia
Completed NCT00943306 - Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia Phase 3
Completed NCT02462655 - Effects of LDL Apheresis System on the Expression of Genes Involved in Lipoprotein Metabolism and Inflammation in Homozygotes for Familial Hypercholesterolemia N/A
Terminated NCT00079859 - Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy Phase 2
Recruiting NCT05066932 - Advanced Lipoproptein Profiling and Cardiovascular Risk Stratification in Familial Hypercholesterolemia
Completed NCT02709850 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia Phase 1
Active, not recruiting NCT03832985 - Pediatric Reporting of Adult-Onset Genomic Results Early Phase 1
Terminated NCT02013713 - French Observatory of Familial Hypercholesterolemia in Cardiology
Recruiting NCT02009345 - Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada
Terminated NCT03331666 - Impact of LDL-cholesterol Lowering on Platelet Activation Phase 4