Unstable Angina Pectoris in Comorbidity With Anxiety-depressive Syndrome

NCT04599621 | Recruiting DMC FDA Device

• 1 other identifier: DGU20191075
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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 \[Psychiatry - Gofman A.G. 2010\].

Conditions

Coronary Heart Disease

Keywords

unstable angina pectoris; uric acid; cytokine imbalance

Outcome Measures

Primary Outcomes (3)

• 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.

  2019-2027

• 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.

  2019-2027

• 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.

  2019-2027

Secondary Outcomes (1)

• etermination of uric acid level

  2019-2027

Study Arms (1)

patients with unstable angina

This group included patients with frequent anginal attacks, with a burdened history and comorbid conditions.

Diagnostic Test: 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

Interventions

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_TEST

Collection 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.

patients with unstable angina

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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;
• History of acute or chronic psychosis;
• The presence of concomitant acute diseases or chronic diseases in the acute stage.
• Throughout the study, all patients were assigned the right to voluntarily withdraw from the study at their own request, notifying the researcher in writing or orally.

Sponsors & Collaborators

• Samarkand State Medical Institute: lead

Study Sites (1)

Zarina

Samarkand, 140100, Uzbekistan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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). 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.

MeSH Terms

Conditions

Coronary Disease; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zarina Nasirova, PhD

CONTACT

+998902768950; zarina.nasirova.91@mail.ru

Eleonora Tashkenbayeva, PhD

CONTACT

+998902811880; Eleonora_88@mail.ru

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 23, 2020
• Study Start: November 5, 2018
• Primary Completion: December 25, 2025
• Study Completion (Estimated): December 28, 2027
• Last Updated: October 23, 2020

Record last verified: 2020-04

Locations

UZ (1)