Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated HF With Ischemic Systolic Dysfunction (FHID)
Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated Heart Failure With Ischemic Systolic Dysfunction
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Important reason for the development of chronic heart failure is a viral disease of the heart, the three phenotypes associated with: the presence of inflammation without viral agent, implying an autoimmune disease; presence of inflammation and persistent viruses; and the presence of persistent virus without signs of inflammation.
There is a group of patients with coronary heart disease, which on the background of optimal treatment is observed progression of clinical symptoms of coronary heart disease with the subsequent development of heart failure, leading to ischemic cardiomyopathy. Perhaps the reason for this is the combination of inflammatory and ischemic cardiomyopathies.
Inflammatory cardiomyopathy, involved in the pathogenesis of DCM, includes idiopathic, autoimmune and infectious subtypes. Inflammatory disease of the myocardium diagnosed by established histological, immunological and immunohistochemical criteria.
This study will include 60 patients with decompensated heart failure with ischemic left ventricular systolic dysfunction (LVEF <40%) were hospitalized not earlier than 6 months after myocardial revascularization. This group of patients will receive standard treatment, according to national guidelines RSC and ESC, to stabilize heart failure. All patients will be held PCI to exclude ischemic heart failure decompensation. Also, all patients will be performed endomyocardial biopsy as a result of immunohistochemical studies will be made on the separation of the virus and the virus-negative-positive group. After that, the group will be divided into subgroups: virus - and inflammation in the myocardium inflammation without viral antigen, viral inflammation of the presence of antigen and the group with the presence of viral antigen without any signs of inflammation in the myocardium.
The study is nonrandomized.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tomsk, Federación Rusa, 634012
- Reclutamiento
- Scientific and Research Institution of Cardiology of Siberian Department of RAMS
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Investigador principal:
- Vyacheslav Ryabov, MD, PhD
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Contacto:
- Vyacheslav Ryabov, MD, Phd
- Número de teléfono: +73822553689
- Correo electrónico: rvvt@cardio.tsu.ru
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Tomskii region
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Tomsk, Tomskii region, Federación Rusa, 634012
- Reclutamiento
- Research Institutite for Cardiology
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Contacto:
- Vyacheslav Ryabov, MD, Phd
- Número de teléfono: +73822553689
- Correo electrónico: rvvt@cardio-tomsk.ru
-
Investigador principal:
- Vyacheslav Ryabov, MD, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Men and women over the age of 18 years old and weighing up to 130 kg
- Clinical symptoms of decompensated heart failure in history
- Heart failure decompensation requiring hospitalization for at least 3 of the following symptoms: shortness of breath, or position orthopnea, rales, peripheral edema, jugular venous pulsations, signs of stagnation in the pulmonary circulation according to the X-ray of the chest
- Confirmed coronary heart disease with diastolic dysfunction (LVEF <40%) in history and at the time of admission
- The term of the inclusion of patients in the study did not earlier than six months after revascularization (PCI or CABG)
- Patients receiving medical treatment according to national guidelines RSC and ESC with individually tailored doses of drugs
Exclusion Criteria:
- The refusal of a patient to conduct the necessary studies
- Poor visualization of the heart when ultrasound
- Hemodynamically significant valvular heart disease
- Acute coronary syndrome
- Тhrombosis of the right atrium and right ventricle
- Condition after the operation, impeding access to the right ventricle (cava filters plication vena cava, Mustard or Senning operation on the d-transposition of the great arteries, a mechanical prosthetic tricuspid valve)
- Severe comorbidities
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: chronic inflammation
All patients will be held PCI to exclude ischemic heart failure decompensation.
Also, all patients will be performed endomyocardial biopsy.
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Endomyocardial biopsy will be performed through a puncture in the femoral vein.
3-6 samples taken under the control of myocardial echocardiography or flyuroskopii.
Samples of biopsy material then transmitted Pathomorphology for immunohistochemistry, light microscope.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence of inflammatory infiltrate in the myocardial tissue
Periodo de tiempo: 6 month after PCI or CABG
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6 month after PCI or CABG
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue
Periodo de tiempo: 6 month after PCI or CABG
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6 month after PCI or CABG
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The most frequent viral agents in myocardial tissue in this region
Periodo de tiempo: 6 month after PCI or CABG
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6 month after PCI or CABG
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Incidence of the acute myocardial infarction
Periodo de tiempo: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Incidence of disturbance rhythm and conduction of the heart
Periodo de tiempo: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Left ventricular ejection fraction (Echo)
Periodo de tiempo: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Еnd-diastolic volume of the left ventricle (Echo)
Periodo de tiempo: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Еnd-systolic volume of the left ventricle (Echo)
Periodo de tiempo: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Incidence of the mortality
Periodo de tiempo: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Incidence of the stroke
Periodo de tiempo: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Incidence of hospitalizations for decompensation heart failure
Periodo de tiempo: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Vyacheslav Ryabov, MD, PhD, Research Institute for Cardiology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1801
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