Title - National Investigation of Cardiovascular Complications in мetaAbolic syndrome
Brief Title - NICA
Cross-sectional observational study
Principal Investigator - Shlyakhto EV
Scientific Committee - Shlyakhto EV (chairman). Nedogoda S.V.,
Simonova G.I., Konradi A.O.
Executive Committee
Nedoshovin A.O.
Baranova E.I.
Turina T.V., Bolshakova O.O., Yemelyanov I.V., Zvartau N.E., Zelninova T.A., Paskar N.A., Poznyakov Yu.M.
Ethic Committee
Kuleshova E.V., Moroshkin
Observational Committee
Statistics. Bondarenko B.B., Solntsev VN, Bart VA.
Introduction
Despite long-term investigations of the metabolic syndrome (MS) and practical implementation of this term no standard definition of the syndrome is accepted and data of its independent prognostic value are controversial. Nowadays, epidemiology of the syndrome is well studied in West Europe and USA, while data obtained in other regions, in particular in Russian Federation are limited. The prognostic value of MS in Russian population is unknown and the diagnostic criteria specific for the population are not defined. At the same time, regional heterogeneity of risk factors is obvious and can be explained by genetics actors, national features of nutrition, and other behavior factors. Therefore, national study of MS epidemiology and prognostic significance is actual.
Primary Objective: to study epidemiology of risk factors included in MS in Russian Federation, its prognostic value.
Secondary objectives
- To test impact of different definitions in the epidemiology of MS in Russian Federation and select better criteria according to prognostic value
- To study epidemiology of metabolic syndrome in different regions and ethnic groups in Russian Federation
Study population
30 regions of Russian Federation (cities with a population over 500 thousand)
A random sample of 1000 individuals from each region will be examined.
Inclusion criteria
25-75 years (sex and age stratified sample)
Signed informed consent
Study design
The study will consist of 3 phases
Phase 1
NICA 1
Cross-sectional population study of the prevalence of MS and its components in Russian Federation
Sample size – 30 000
Studying parameters
- questionnaires
- height, weight, BMI, waist circumference, hip circumference, neck circumference
- fasting blood sampling (glucose, total cholesterol, TG, HDLP) + genetics
- seating blood pressure (mean value from 3 measurements on right arm)
Phase 2
Instrumental and laboratory examination of patients with risk factors (clinical study)
Selection criteria (one ore more of the following)
- BP ≥ 130/85 mm Hg
- Waist circumference ≥80 sm in females and ≥ 94 in males and/or BMI ≥25 kg/m2
- Dyslipidemia (elevated TG (1,7 mmol/l and/or decreased level of HDLP or therapy for high triglyceride level)
- fasting glucose ≥5,6 mmol/l
Exclusion criteria
Associated clinical conditions (stroke, TIA, IHD, MI, heart failure, renal disease, diabetes mellitus)
Severe concomitant diseases (cancer, liver, kidney)
List of laboratory tests OGTT
Microalbumiuria
HGlA1C
CRP, leptin, adiponectin, insulin (fasting and 2 hour ORTT). homocystein levels
Thyroid hormone levels
Genetic studies (to be discussed)
Lipid profile
List of instrumental tests Echocardiography
- Carotid artery ultrasound (IMT)
- Pulse wave velocity, arterial stiffness and augmentation index (in selected sites)
- Heart rate variability indexes (in selected sites)
- Home blood pressure measurement (4 times per day 2 days)
- Holter monitoring and ABPM
- Densitometry (in selected sites)
- MRI of visceral fat (in selected sites)
- Screening test for obstructive sleep apnea (in selected sites)
Questionnaires
- Sleep apnea
- Depression and anxiety scale
- Cognitive dysfunction (MMSE)
- Quality of life (SF36).
Phase 3
Observation (prognosis)
End-point registration
Therapy registration
End-point registration
Primary – combined cardiovascular endpoint (cardiovascular death, stroke, MI)
Secondary
Fatal and nonfatal stroke
MI
Cardiovascular death
Total mortality
Diabetes mellitus
Heart failure
CAD documented
Revascularization
EDRD
