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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Tomsk、ロシア連邦、634012
- 募集
- Scientific and Research Institution of Cardiology of Siberian Department of RAMS
-
主任研究者：
- Vyacheslav Ryabov, MD, PhD
-
コンタクト：
- Vyacheslav Ryabov, MD, Phd
- 電話番号：+73822553689
- メール：rvvt@cardio.tsu.ru
-
-
Tomskii region
-
Tomsk、Tomskii region、ロシア連邦、634012
- 募集
- Research Institutite for Cardiology
-
コンタクト：
- Vyacheslav Ryabov, MD, Phd
- 電話番号：+73822553689
- メール：rvvt@cardio-tomsk.ru
-
主任研究者：
- Vyacheslav Ryabov, MD, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：chronic inflammation
All patients will be held PCI to exclude ischemic heart failure decompensation.
Also, all patients will be performed endomyocardial biopsy.
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence of inflammatory infiltrate in the myocardial tissue
時間枠：6 month after PCI or CABG
|
6 month after PCI or CABG
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue
時間枠：6 month after PCI or CABG
|
6 month after PCI or CABG
|
|
The most frequent viral agents in myocardial tissue in this region
時間枠：6 month after PCI or CABG
|
6 month after PCI or CABG
|
|
Incidence of the acute myocardial infarction
時間枠：6 and 12 month after PCI or CABG
|
6 and 12 month after PCI or CABG
|
|
Incidence of disturbance rhythm and conduction of the heart
時間枠：6 and 12 month after PCI or CABG
|
6 and 12 month after PCI or CABG
|
|
Left ventricular ejection fraction (Echo)
時間枠：6 and 12 month after PCI or CABG
|
6 and 12 month after PCI or CABG
|
|
Еnd-diastolic volume of the left ventricle (Echo)
時間枠：6 and 12 month after PCI or CABG
|
6 and 12 month after PCI or CABG
|
|
Еnd-systolic volume of the left ventricle (Echo)
時間枠：6 and 12 month after PCI or CABG
|
6 and 12 month after PCI or CABG
|
|
Incidence of the mortality
時間枠：6 and 12 month after PCI or CABG
|
6 and 12 month after PCI or CABG
|
|
Incidence of the stroke
時間枠：6 and 12 month after PCI or CABG
|
6 and 12 month after PCI or CABG
|
|
Incidence of hospitalizations for decompensation heart failure
時間枠：6 and 12 month after PCI or CABG
|
6 and 12 month after PCI or CABG
|
協力者と研究者
捜査官
- 主任研究者：Vyacheslav Ryabov, MD, PhD、Research Institute for Cardiology
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。