Clinical trial NCT01221584: Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia
Official title: Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidaemia
Keywords: Dyslipidaemia
LDL-C goals
guidelines
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks..

Brief summary: The purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific Cardiology Society guidelines/ the 4th Joint European Task Force guidelines.


Eligibility criteria: Inclusion Criteria:

* Subject must be 18 years of age or older of either gender or race.
* Subject must provide informed consent and comply with the survey procedures.
* Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent

Primary outcomes:
measure: Establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific Cardiology Society guidelines/the Fourth Joint European Task Force guidelines
timeFrame: 1 visit - 1-3 days
Secondary outcomes:
measure: Establish the proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Russian guidelines in the following sub-populations: Primary/secondary prevention patients, Patients with metabolic syndrome
timeFrame: 1 visit - 1-3 days
measure: Establish the proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the FJETF/ NCEP ATP III guidelines, in all population and in Primary/secondary prevention patients, Patients with metabolic syndrome
timeFrame: 1 visit - 1-3 days
measure: Establish the proportion of patients on lipid-lowering treatment reaching the non HDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines in the sub-population patients with fasting triglycerides >200 mg/dL (2.26mmol/L)
timeFrame: 1 visit - 1-3 days
Other outcomes:
Locations:
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alexey Stepanov, Prof
role: STUDY_DIRECTOR
affiliation: RKNPK
name: Prof. Boytsov
role: PRINCIPAL_INVESTIGATOR
affiliation: Center of preventive medicine
name: Acad Oganov
role: PRINCIPAL_INVESTIGATOR
References: