NCT02649517

Brief Summary

The purpose of the study is to investigate the clinical and morphological characteristics of chronic subclinical inflammation in the myocardium in patients with decompensated heart failure with ischemic systolic dysfunction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

2.1 years

First QC Date

January 4, 2016

Last Update Submit

January 5, 2016

Conditions

Decompensated Heart FailureIschemic Heart Disease

Keywords

decompensated heart failureischemic heart diseaseinflammatory cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Incidence of inflammatory infiltrate in the myocardial tissue

    6 month after PCI or CABG

Secondary Outcomes (10)

  • Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue

    6 month after PCI or CABG

  • The most frequent viral agents in myocardial tissue in this region

    6 month after PCI or CABG

  • Incidence of the acute myocardial infarction

    6 and 12 month after PCI or CABG

  • Incidence of disturbance rhythm and conduction of the heart

    6 and 12 month after PCI or CABG

  • Left ventricular ejection fraction (Echo)

    6 and 12 month after PCI or CABG

  • +5 more secondary outcomes

Study Arms (1)

chronic inflammation

OTHER

All patients will be held PCI to exclude ischemic heart failure decompensation. Also, all patients will be performed endomyocardial biopsy.

Procedure: Endomyocardial biopsy

Interventions

Endomyocardial biopsyPROCEDURE

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.

Also known as: EMB
chronic inflammation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Patients receiving medical treatment according to national guidelines RSC and ESC with individually tailored doses of drugs

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Institutite for Cardiology

Tomsk, Tomskii Region, 634012, Russia

RECRUITING

Scientific and Research Institution of Cardiology of Siberian Department of RAMS

Tomsk, 634012, Russia

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Vyacheslav Ryabov, MD, PhD

    Research Institute for Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vyacheslav Ryabov, MD, PhD

CONTACT

+73822553689rvvt@cardio-tomsk.ru

Ekaterina Krychinkina, MD

CONTACT

+73822558360katy990@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD Research Institute for Cardiology

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 7, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2018

Study Completion

October 1, 2018

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

RU(2)