Coronary Artery Disease, Coronary Artery Stenosis, Coronary Atherosclerosis, Ischemic Heart Disease
Conditions
Keywords
Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Right coronary artery, Stress-MRI
Brief summary
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.
Interventions
DRUGOptimal medicamentous treatment
PROCEDUREStress-MRI
A standard stress-MRI test with adenosine
PROCEDURECTO coronary angioplasty
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.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress-MRI evaluation | Within 2 and 12 month after hospitalization | High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical assessment | Within 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 moths after hospitalization | Dynamical assessment of stable angina FC (CCS) and dyspnea FC (NYHA) |
| Stress-MRI evaluation (2) | Within 2 and 12 month after hospitalization | Dynamics of perfusion in myocardium scar tissue according to stress-MRI data |
| Major adverse cardiac and cerebrovascular events (MACCE) | During 1 year after first stress-MRI assessment | 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. |
Countries
Russia
Outcome results
None listed