- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02649517
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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Vyacheslav Ryabov, MD, Phd
- 전화번호: +73822553689
- 이메일: rvvt@cardio-tomsk.ru
연구 연락처 백업
- 이름: Ekaterina Krychinkina, MD
- 전화번호: +73822558360
- 이메일: katy990@mail.ru
연구 장소
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Tomsk, 러시아 연방, 634012
- 모병
- Scientific and Research Institution of Cardiology of Siberian Department of RAMS
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수석 연구원:
- Vyacheslav Ryabov, MD, PhD
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연락하다:
- Vyacheslav Ryabov, MD, Phd
- 전화번호: +73822553689
- 이메일: rvvt@cardio.tsu.ru
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Tomskii region
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Tomsk, Tomskii region, 러시아 연방, 634012
- 모병
- Research Institutite for Cardiology
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연락하다:
- Vyacheslav Ryabov, MD, Phd
- 전화번호: +73822553689
- 이메일: rvvt@cardio-tomsk.ru
-
수석 연구원:
- Vyacheslav Ryabov, MD, PhD
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Incidence of inflammatory infiltrate in the myocardial tissue
기간: 6 month after PCI or CABG
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6 month after PCI or CABG
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2차 결과 측정
결과 측정 |
기간 |
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Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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공동 작업자 및 조사자
수사관
- 수석 연구원: Vyacheslav Ryabov, MD, PhD, Research Institute for Cardiology
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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