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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress-MRI + Chronic total occlusion PCI | Experimental | Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO |
|
| Stress-MRI + Optimal medicamentous treatment | Active Comparator | Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTO coronary angioplasty | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Within 2 and 12 month after hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical assessment | Dynamical assessment of stable angina FC (CCS) and dyspnea FC (NYHA) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Research Institute of CIrculation Pathology | Novosibirsk | 630055 | Russia |
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|
| Optimal medicamentous treatment | Drug |
|
| Stress-MRI | Procedure | A standard stress-MRI test with adenosine |
|
| 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. | During 1 year after first stress-MRI assessment |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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