Unstable Angina Pectoris in Comorbidity With Anxiety-depressive Syndrome

Coronary Heart Disease Clinical Trial

Official title: Immunological Features of Unstable Angina Pectoris in Comorbidity With Anxiety-depressive Syndrome

Status Recruiting

Clinical Trial Summary

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].

Clinical Trial Description

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 (pg/ml) in blood serum by enzyme-linked immunosorbent assay (ELISA).

Sample preparation: before testing, 1 part of the plasma is diluted 30-50 times with Tris buffer, depending on the test system and the kit manufacturer's instructions.

Definition progress:

1. preparation of microtiter strips;

2. add the material diluted with buffer to the well of the microtiter strip and incubate for 1 hour at room temperature;

3. washing;

4. add immunoconjugates to the well of the microtiter strip and incubate for 1 hour at room temperature;

5. washing;

6. add the o-phenyldiamine / H2O2 substrate solution;

7. after exactly 3 minutes of hydrochloric acid (1 mol / l);

8. reading the results on an ELISA analyzer after 10-120 minutes. 2.4. Collection of blood samples to determine the level of uric acid 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.

2.5. Method for determining anxiety-depressive syndrome. When examining patients with unstable angina pectoris were used: Hospital 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].

Description of the hospital scale This questionnaire is intended for self-completion by the patient [Kozlova S.N. 2013]. The questionnaire consists of 14 statements, "serving" 2 subscales: the subscale "alarm" marked in red, consists of odd items - 1, 3, 5, 7, 9, 11, 13 and the subscale "depression" marked in blue consists of even items - 2, 4, 6, 8, 10, 12, 14.

Each statement corresponds to 4 answer options, reflecting gradations of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). The final scores for the two subscales are obtained by summing the numerical values of the answers. When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values:

• 0-7 - normal (no reliably pronounced symptoms of anxiety and depression);

• 8-10 - subclinical anxiety and / or depression;

• 11 and above - clinically significant anxiety and / or depression. The filling of the scale was carried out by patients under standard conditions, after a short instruction for filling, within a clear time frame.

Description of the Spielberger-Hanin scale The Spielberger Anxiety Scale is an informative way to self-assess the level of anxiety at a given moment (reactive anxiety as a state) and personal anxiety (as a stable characteristic of a person). Developed by Ch.D.Spielberger and adapted by Yu.L. Khanin [Psychiatry - Gofman A.G. 2010].

This scale consists of two subscales: judgments from 1 to 20 determine the presence of situational anxiety, judgments from 21 to 40 determine the presence of personal anxiety.

When analyzing the results of self-assessment, it should be borne in mind that the overall final indicator for each of the subscales can range from 20 to 80 points. Moreover, the higher the final indicator, the higher the level of anxiety (situational or personal).

When interpreting indicators, you can use the following rough estimates of anxiety:

• up to 40 points - low,

• 41 - 54 points - moderate;

• 55 and more - high. 2.6. Treatment All patients with unstable angina pectoris offer conventional therapy, which includes intravenous infusion of nitrates for 12-24 hours, followed by prolonged nitrates, beta-blockers, ACE inhibitors or sartans, antiplatelet agents, anticoagulants, clopidogrel, statins. Patients have elevated levels of uric acid according to the traditional immedia Febuxostat (not a purine blocker of xanthine oxide, manufactured by Berlin Chemie, Germany) at a dose of 0.04-0.08 g / day per day. Patients who had anxiety-depressive syndrome Divase syndrome (antibodies to the brain-specific protein S-100, manufacturer MATERIA MEDICA HOLDING, LLC (Russia)) in a fixed dose of 0.6 mg / day, which has a neurotropic and antioxidant effect. ;

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Depressive Disorder
• Heart Diseases
• Myocardial Ischemia

• NCT number: NCT04599621
• Study type: Observational
• Source: Samarkand State Medical Institute
• Contact: Zarina Nasirova, PhD
• Phone: +998902768950
• Email: zarina.nasirova.91@mail.ru
• Status: Recruiting
• Start date: November 5, 2018
• Completion date: December 28, 2027