Arrhythmias, Cardiac, Cardiovascular Diseases, Coronary Disease, Menopause, Premature, Polymorphism, Single Nucleotide, Primary Ovarian Insufficiency, Pulmonary Embolism
Conditions
Keywords
premature ovarian failure, hypoestrogenism, artificial menopause, cardiovascular disease, chronic non-infectious disease, cardiovascular outcomes, coronary heart disease, pulmonary embolism, cardiac arrhythmias, heart rhythm disturbances, single nucleotide polymorphisms
Brief summary
Research objective. \- To study the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with non-communicable diseases and adverse outcomes in women with premature ovarian failure. Research objectives: * To study the associations between combinations of single-nucleotide polymorphisms and behavioural risk factors with heart rate disorders and adverse outcomes in women with premature ovarian failure * Examine the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with stable STIs in women with premature ovarian failure. * Examine the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with thrombomolia in women with premature ovarian failure * Study the associations between combinations of single nucleotide polymorphisms and behavioural risk factors and adverse cardiovascular outcomes in women with premature ovarian failure.
Detailed description
Methods of research: * Questionnaire . * Clinical examination * Blood levels of sex hormones * Blood lipid spectrum * Coagulogram * Glycemic profile * EchoCG * SMAD * ECG * Daily ECG monitoring * Questionnaire EQ-5D * Single-nucleotide polymorphisms of genes of the reninangyotensin-aldosterone system group (AGT, ACE), endothelial dysfunction (NOS3, EDN1), thrombosis-associated (ITGB3, ITGA2, FGB, GPIBA, SERPINE PAI1), pro-inflammatory (CRP, IL17A, IL2, IL10 1, IL10 2, TNFα, CRP 4, IL6, TLR2, TLR3, TLR4, TLR6, TLR9) polymorphisms. Subject of study. Women under 45 with Premature Ovarian Failure (PED). It is planned to include 615 people in the study. The study will have both prospective and retrospective parts. Patients will be divided into 4 groups: * Women with OED without cardiovascular disease * Women with OAI who have cardiovascular disease * Control group No 1 Women with normal ovarian function without cardiovascular disease. * Control group 2 Women with normal ovarian function without cardiovascular disease. The groups will be comparable in number. All data obtained will be calculated for each group separately. A comparative analysis will then be made for all four groups. Traditional risk factors, existing non-communicable diseases and the quality of life of patients will be identified using standard research methods. The selected polymorphism groups are associated with various pathological processes leading to unfavourable cardiovascular outcomes. Their role has not been assessed in patients with premature ovarian failure. The power of the study was calculated based on the expected number of adverse outcomes. The division of patients into groups is related to the need to compare and evaluate unfavourable outcomes and non-communicable diseases in patients in order to create a risk scale.
Interventions
BEHAVIORALTaking a person's venous blood
Collection of 5 ml of the patient's venous blood, carried out according to standard rules.
Sponsors
Ryazan State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Women diagnosed with premature ovarian failure were selected from different medical institutions in Ryazan and the Ryazan region, all information was communicated to them in a clear and understandable way and they also signed an informed voluntary consent. Premature ovarian failure - defined as the occurrence of secondary amenorrhoea ≥4 months at the age of under 45 years together with FSH levels above 40 IU/L. Inclusion criteria were: female gender, age at menopause \< 45 years, onset of secondary amenorrhoea ≥ 4 months, FSH levels higher than 40 IU/l, or a previous diagnosis of premature ovarian failure. The control group was formed based on comparability criteria of gender, age and BMI to minimise the influence of phenotype on the results. The control group consisted of women without signs of PEN, so we aimed to compare the health status of these two different groups of women.
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* women under 45 years old * presence of premature ovarian insufficiency in the medical history
Exclusion criteria
* male gender * age over 45 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Age (years) | 2 year | Patient age in years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menarche (years) | 2 year | Age of onset of menarche expressed in years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diastolic blood pressure (mmHg) | 2 year | Diastolic blood pressure measured using the standard method |
| Heart rate (number) | 2 year | Heart rate measured using the standard method |
| Radial artery pulse (beats per minute). | 2 year | Radial artery pulse measured using standard methods |
| Arterial hypertension (yes/no) | 2 year | History of arterial hypertension |
| Ultrasound examination of the heart | 2 year | Ultrasound examination of the heart carried out using standard methods to detect cardiac abnormalities |
| Total cholesterol (mmol/l) | 2 year | Total cholesterol measured by standard methods |
| High-density lipoproteins (HDL) (mmol/l) | 2 year | High-density lipoproteins measured by standard methods |
| Low density lipoproteins LDL (mmol/l) | 2 year | Low density lipoproteins measured by standard methods |
| Triglycerides (mmol/l) | 2 year | Triglycerides measured by standard methods |
| Cholesterol/HDL ratio (number) | 2 year | Calculated using the standard method |
| Blood glucose level (mmol/l) | 2 year | Amount of glucose in the blood measured by the standard method |
| Pregnancy (number) | 2 year | Number of pregnancies in history |
| Childbirth (number) | 2 year | Number of pregnancies that ended in childbirth |
| Menopause (yes/no) | 2 year | Current presence or absence of menopause |
| Surgical removal of both ovaries (yes/no) | 2 year | History of surgery involving bilateral removal of both ovaries |
| Presence of amenorrhoea (at least 4 months) (yes/no) | 2 year | A history of amenorrhoea for at least 4 months |
| Follicle stimulating hormone (FSH) level (mMed/ml) | 2 year | Blood follicle-stimulating hormone content expressed in mMED/ml |
| Age at menopause (years) | 2 year | Age of onset of menopause |
| Length of post-menopause (years) | 2 year | How many years a person has been in the post-menopausal phase |
| Taking oral contraceptives (yes/no) | 2 year | Whether the patient is continuously taking oral contraceptives |
| Taking hormone replacement therapy (HRT) (yes/no) | 2 year | Whether the patient is taking regular hormone replacement therapy |
| Length of time on hormone replacement therapy (years) | 2 year | How long the patient has been on hormone replacement therapy |
| Smoking status (yes/no) | 2 year | Does the patient use nicotine-containing substances on a regular basis |
| Number of cigarettes smoked per day (number) | 2 year | How many cigarettes the patient smokes per day on average |
| Smoking experience (years) | 2 year | Number of years of active nicotine use by the patient |
| Smoking index (points) | 2 year | Calculated as the number of cigarettes smoked per day and years of smoking experience divided by 20. |
| Height (cm) | 2 year | Patient's height measured in centimetres |
| Weight (kg) | 2 year | Patient weight measured in kilograms |
| BMI (kg/m2) | 2 year | Body mass index is determined using the standard method |
| Waist circumference (cm) | 2 year | Waist circumference measured in centimetres using the standard method |
| Hip circumference (cm) | 2 year | Hip circumference measured in centimetres using the standard method |
| Waist circumference to hip circumference ratio (WHR) (number) | 2 year | Waist circumference to hip circumference index calculated using the standard method |
| Secondary education (yes/no) | 2 year | Does the patient have a high school education |
| Secondary vocational education (yes/no) | 2 year | Does the patient have a secondary vocational education |
| Glycated haemoglobin (HbA1c), (percent %) | 2 year | Glycated haemoglobin measured by standard methods |
| Diabetes mellitus (yes/no) | 2 year | Indication of diabetes mellitus in the patient's medical history |
| Taking antihypertensive medication (yes/no) | 2 year | Indication of antihypertensive medication in the patient's medical history |
| Taking hypolipidemic medicines (yes/no) | 2 year | Use of hypolipidemic drugs in a patient's history |
| Metabolic syndrome (yes/no) | 2 year | Indicating a history of metabolic syndrome |
| Presence of post-menopausal diagnosis: arrhythmia or other rhythm disturbances (yes/no) | 2 year | Post-menopausal diagnosis of arrhythmia or other rhythm disturbances based on medical history |
| Presence of a post-menopausal diagnosis of coronary heart disease (yes/no) | 2 year | Presence of post-menopausal diagnosis of coronary heart disease according to medical history |
| Presence of a post-menopausal diagnosis of myocardial infarction (yes/no) | 2 year | Post-menopausal diagnosis of myocardial infarction based on medical history |
| Presence of post-menopausal diagnosis: thromboembolism (yes/no) | 2 year | Post-menopausal diagnosis of thromboembolism based on medical history |
| Post-menopausal diagnosis of varicose veins in the lower limbs (yes/no) | 2 year | Post-menopausal diagnosis of varicose veins in the lower limbs based on medical history |
| Presence of a post-menopausal diagnosis: Acute cerebral haemorrhage (yes/no) | 2 year | Post-menopausal diagnosis of acute cerebral haemorrhage on medical history |
| Deaths from cardiovascular disease in the post-menopausal period (yes/no) | 2 year | Cardiovascular deaths in the post-menopausal period based on the pathologist's medical history report |
| A history of cancer (yes/no) | 2 year | Determined on the basis of the medical history |
| AGT gene Met235Thr, rs699 polymorphism | 2 year | Identification of Met235Thr/rs699 polymorphisms in the AGT gene |
| ACE gene Alu Ins/Del I>D, rs4646994 polymorphism | 2 year | Identification of Alu Ins/Del I\>D, rs4646994 polymorphisms in the ACE gene |
| NOS3 gene C786T, rs2070744 polymorphism | 2 year | Identification of C786T, rs2070744 polymorphisms in the NOS3 gene |
| EDN1 gene Lys198Asn, rs5370 polymorphism | 2 year | Identification of Lys198Asn, rs5370 polymorphisms in the EDN1 gene |
| ITGB3 gene Leu33Pro, rs5918 polymorphism | 2 year | Identification of Leu33Pro, rs5918 polymorphisms in the ITGB3 gene |
| ITGA2 gene C807T, rs1126643 polymorphism | 2 year | Identification of C807T, rs1126643 polymorphisms in the ITGA2 gene |
| FGB gene 455G-A, rs1800790 polymorphism | 2 year | Identification of 455G-A, rs1800790 polymorphisms in the FGB gene |
| SERPINE (PAI) 1 gene 675 5G/4G, rs1799768 polymorphism | 2 year | Identification of 675 5G/4G, rs1799768 polymorphisms in the SERPINE (PAI) 1 gene |
| CRP gene C3872T, rs1205 polymorphism | 2 year | Identification of C3872T, rs1205 polymorphisms in the CRP gene |
| IL17A gene G-197A, rs2275913 polymorphism | 2 year | Identification of G-197A, rs2275913 polymorphisms in the IL17A gene |
| IL2 gene T-330G, rs2069762 polymorphism | 2 year | Identification of T-330G, rs2069762 polymorphisms in the IL2 gene |
| IL10 gene C-592A, rs1800872 polymorphism | 2 year | Identification of C-592A, rs1800872 polymorphisms in the IL10 gene |
| TNF gene G-308A, rs1800629 polymorphism | 2 year | Identification of G-308A, rs1800629 polymorphisms in the TNF gene |
| Higher education (yes/no) | 2 year | Does the patient have a university degree |
| IL6 gene C-174G, rs1800795 polymorphism | 2 year | Identification of C-174G, rs1800795 polymorphisms in the IL6 gene |
| TLR2 gene Arg753Gln, rs5743708 polymorphism | 2 year | Identification of Arg753Gln, rs5743708 polymorphisms in the TLR2 gene |
| TLR3 gene Phe412Leu, rs3775291 polymorphism | 2 year | Identification of Phe412Leu, rs3775291 polymorphisms in the TLR3 gene |
| TLR4 gene Asp299Gly, rs4986790 polymorphism | 2 year | Identification of Asp299Gly, rs4986790 polymorphisms in the TLR4 gene |
| TLR6 gene Ser249Pro, rs5743810 polymorphism | 2 year | Identification of Ser249Pro, rs5743810 polymorphisms in the TLR6 gene |
| TLR9 gene T-1237C, rs5743836 polymorphism | 2 year | Identification of T-1237C, rs5743836 polymorphisms in the TLR9 gene |
| CRP gene A-717G, rs2794521 polymorphism | 2 year | Identification of A-717G, rs2794521 polymorphisms in the CRP gene |
| Systolic blood pressure (mmHg) | 2 year | Systolic blood pressure measured using the standard method |
Countries
Russia
Outcome results
None listed