Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

Meshalkin Research Institute of Pathology of Circulation72 enrolled

Overview

The hypothesis of this study is that Stress-MRI is a clinically significant method of myocardial perfusion assessment after coronary angioplasty with stenting of right coronary artery (RCA) chronic total occlusion (CTO) is performed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ischemic Heart Disease Coronary Atherosclerosis Coronary Artery Disease Coronary Artery Stenosis

Interventions

CTO coronary angioplastyPROCEDURE

A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.

Optimal medicamentous treatmentDRUG

Stress-MRI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stable angina, CCS FC II-IV * "Right-dominance" coronary circulation according to coronary angiography * Absence of other significant atherosclerotic coronary lesions (more than 65%) * High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest) * Signed, documented informed consent prior to admission to the study Exclusion Criteria: * Acute coronary syndrome * Contraindications for adenosine stress test * Low and moderate risk of myocardium ischemia according to stress-MRI data (perfusion defect in less than 2 segments in the area of interest)

Locations (1)

State Research Institute of CIrculation Pathology

Novosibirsk, Russia

Outcomes

Primary Outcomes

Stress-MRI evaluation

High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)

Time frame: Within 2 and 12 month after hospitalization

Secondary Outcomes

Clinical assessment

Dynamical assessment of stable angina FC (CCS) and dyspnea FC (NYHA)

Time frame: Within 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 moths after hospitalization

Stress-MRI evaluation (2)

Dynamics of perfusion in myocardium scar tissue according to stress-MRI data

Time frame: Within 2 and 12 month after hospitalization

Major adverse cardiac and cerebrovascular events (MACCE)

Major adverse cardiac and cerebrovascular events (MACCE) including: All-cause mortality, Myocardial infarction, Stroke, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization.

Time frame: During 1 year after first stress-MRI assessment

Data from ClinicalTrials.gov

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