Screens Russians for underdiagnosed familial hypercholesterolemia and tracks their care
Studies how often inherited high cholesterol goes undiagnosed and untreated in Russia.
Plain-language title generated from the registry record
Registry title: Russian Familial Hypercholesterolemia Registry
Key facts
- Where
- Chelyabinsk, Moscow, Novosibirsk, Saint Petersburg, and Samara, RussiaSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 80 years old?
Source: NCT02208869, who can take part
Where in Russia
- Chelyabinsk State Medical AcademyChelyabinsk, RussiaNot yet recruiting
- EI Chazov National Medical Research Center of CardiologyMoscow, RussiaTaking people
- Novosibirsk Research Institute of Internal Medicine, Institute of Internal Medicine Siberian Branch of the Russian Academy of Medical SciencesNovosibirsk, RussiaNot yet recruiting
- Saint-Petersburg State University and North-West State Medical University n.a. I.I.MechnikovSaint Petersburg, RussiaNot yet recruiting
- Samara State Medical UniversitySamara, RussiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Russian Cardiology Research and Production Center
- Trial code
- NCT02208869
- Record updated
- 2 November 2022
- Original description
True prevalence of FH in the Russian Federation is unknown which leads to low percentage of diagnosed and treated cases. Research is needed to determine the prevalence of FH, specific diagnostic algorithms and optimal treatment strategies. The main aim of the present study is to evaluate the extent to which FH is underdiagnosed and undertreated in the Russian Federation for reduction of cardiovascular risk related to atherosclerosis in the country.Read full original descriptionShow less
Prospective Russian Study Evaluating the Extent of Underdiagnosed and Undertreated of Familial Hypercholesterolaemia in the Population
True prevalence of FH in the Russian Federation is unknown which leads to low percentage of diagnosed and treated cases. Research is needed to determine the prevalence of FH, specific diagnostic algorithms and optimal treatment strategies. The main aim of the present study is to evaluate the extent to which FH is underdiagnosed and undertreated in the Russian Federation for reduction of cardiovascular risk related to atherosclerosis in the country.
As a first step, total cholesterol (TC) and low-density lipoprotein (LDL-C) levels will be determined in a random sample from Moscow population (n=18000). It is expected that TC ≥ 7.5 mmol/L will be detected in 10% of cohort. During 2014, approximately 500 patients will pass through non-invasive clinical examination at the Russian Cardiology Research and Production Center, including patient demographics, past medical history, family history of hypercholesterolemia, physical findings, current lipid-lowering therapies, blood tests, genetic analysis, echocardiography, carotid duplex ultrasound and exercise SPECT imaging in selected cases. On the basis of the Moscow Program four major Federal Medical Centers will be involved, and FH Registry will be created as a national, multi-center initiative to screen FH patients, control their diagnosis and management, and track clinical-reported outcomes over time.
Establishment of National Guidelines for the diagnosis and treatment of FH on the basis of these data and implementation those into clinical practice in different regions of Russia will allow improving patient care. As an expected outcome, this program will raise awareness and increase appropriate assessment and treatment of FH patients in Russia, leading to a timely detection of the disease and therapy initiation.
Inclusion: Total cholesterol ≥7.5 mmol/L or LDL-C ≥4.9 mmol/L (pretreatment levels); Familial hypercholesterolemia defined as: a. Mutation in the LDL receptor and/or the ApoB gene and/or the PCSK9 gene; or b. clinical diagnosis of heterozygous FH (HeFH) according to the Dutch Lipid Network Criteria or Simon Broom Criteria; Patients with genetic mutation of FH.
Exclusion: uncontrolled primary hypothyroidism (thyroid stimulating hormone (TSH) >1.5 x upper limit of normal (ULN)),; nephrotic syndrome and/or renal dysfunction (scrum creatinine >2.0 mg/dL or 160mmol/l, creatinine clearance <15 ml/min) at screening; uncontrolled diabetes mellitus (Glycated hemoglobin >8.5%).