Unstable Angina Pectoris in Comorbidity With Anxiety-depressive Syndrome
ConditionCoronary Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSamarkand State Medical Institute
About this trial
Introduction:
Today it is necessary to emphasize that coronary heart disease is often associated with anxiety disorders. Research over the years has shown several and sometimes surprising links between coronary heart disease and mental illness, and has even suggested that both of these phenomena may actually cause each other. However, the exact nature of these links has not yet been clearly established.
Methods: The study included 202 patients with coronary artery disease, of whom 42 patients were with stable angina pectoris, they participated as a control group, and 160 patients with unstable angina pectoris, who made up the main group.
Among them there are 102 women and 100 men between the ages of 30 and 88. The average age was 63.75 ± 11.37 years.
All study participants had blood in the morning on fasting after 8-12 hours of fasting from the cubital vein. Determination of the level of cytokines TNF-α, IL-1β, IL-4 and IL-10 in blood serum by enzyme-linked immunosorbent assay (ELISA).
All participants in the study had blood drawn in the morning on fasting after 8-12 hours of fasting from the cubital vein. The level of uric acid was determined on the CYAN Start apparatus using a unified method.
When examining patients with unstable angina pectoris were used: hospital anxiety and depression scale \[Kozlova S.N. 2013\]. And also the Spielberger-Khanin scale \[Psychiatry - Hoffman A.G. 2010\], developed by Spielberger Ch.D. and adapted by Yu.L. Khanin. to assess cognitive functions \[Psychiatry - Gofman A.G. 2010\].
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
the presence of an established diagnosis in patients with coronary artery disease
unstable angina pectoris (NS). When making a diagnosis, the recommendations of ESH / ESC (2015) and RCO / WHO (2014) were used.
stable exertional angina (SSN) I-III FC. When making the diagnosis, the IHD classification was used, adopted at the IV Congress of Cardiologists of the Republic of Uzbekistan (2000), as well as in accordance with the recommendations of ESH / ESC (2019) and RCO / WHO (2017)
Disqualifiers
The patient's refusal to participate in the study;
Pregnancy and lactation;
Severe and unstable condition of the patient, making it difficult to conduct a questionnaire (for ethical reasons);
Acute violation of cerebral circulation;
Trial population
When collecting anamnesis in patients with unstable angina pectoris, the presence of ischemic heart disease (previous MI, exertional or rest angina pectoris), the presence of risk factors for coronary artery disease and myocardial infarction (atherosclerosis of other vascular areas, hypertension, smoking, diabetes mellitus, obesity) was determined. When questioning the patient, attention was paid to the period preceding the development of myocardial infarction, as well as the factors that provoked the development of this disease (excessive physical activity, infections, psychoemotional stress), as well as information on the early manifestation of CVD in the closest relatives.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Collection of blood samples to determine the level of certain cytokines (TNF-α, IL-1β, IL-4 and IL-10),Collection of blood samples to determine the level of uric acid
Diagnostic testCollection of blood samples to determine the level of certain cytokines (TNF-α, IL-1β, IL-4 and IL-10) All study participants had blood in the morning on fasting after 8-12 hours of fasting from the cubital vein. Determination of the level of cytokines TNF-α, IL-1β, IL-4 and IL-10 in blood serum by enzyme-linked immunosorbent assay (ELISA). All participants in the study had blood drawn in the morning on fasting after 8-12 hours of fasting from the cubital vein. The level of uric acid was determined on the CYAN Start apparatus using a unified method.
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: patients with unstable angina1 intervention
Trial outcomes
Primary outcomes
1
cytokine research
Determination of the level of cytokines TNF-α, IL-1β, IL-4 and IL-10 in blood serum was performed by enzyme-linked immunosorbent assay (ELISA). The principle of operation of the test system for the determination of cytokines is based on the "sandwich" method of solid-phase immune enzyme immunoassay using horseradish peroxidase as an indicator enzyme. Stop the reaction by adding 50 μl of 1N sulfuric acid solution. The quantitative assessment of the results is carried out by the method of constructing a calibration curve or using a commercial computer program "Microplate manager", reflecting the dependence of optical density on concentration for a standard antigen and allowing comparison of the test samples with it. The sensitivity of the method is 5-30 pg / ml.
Time frame
2019-20272
hospital scale
The questionnaire consists of 14 questions, 2 subscales. 0-7 - normal, 8-10 - subclinical anxiety or depression; 11 and above - clinically significant anxiety or depression.
Time frame
2019-20273
Spielberger-Khanin Anxiety Scale
The scale consists of 2 subscales: judgments from 1 to 20 determine situational anxiety, judgments from 21 to 40 determine the presence of personal anxiety. The results for each subscale can be from 20 to 80 points. up to 40 points - low, 41 - 54 points - moderate; 55 and more - high.
Time frame
2019-2027Secondary outcomes
1
etermination of uric acid level
Method: Enzymatic Uricase Colorimetric Method Analyzer: Cobas 6000 Measurement units: μmol / l Material for research: venous blood serum Training: Take on an empty stomach (after sleep and 8-12 hours of fasting). It is permissible to drink only pure non-carbonated water (up to 200 ml) (with the exception of glucose analysis). Do not eat spicy, fatty, fried foods for 1-2 days before analysis. Eliminate physical and emotional stress 1 day before the analysis. Do not smoke for at least 1 hour before analysis. It is not recommended to take it after radiography, physiotherapy procedures and instrumental examinations. For several days before the study, you must adhere to a low-purine diet, avoid drinking alcohol or warn about the use when taking a test.
Time frame
2019-2027Sponsors and contacts
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Source ClinicalTrials.gov