Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Significance of Stress-MRI Evaluation of Right Coronary Artery Chronic Total Occlusion Recanalization Efficacy in Patients With Coronary Artery Disease.

Conditions
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Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease, Coronary Artery Stenosis

Intervention / Treatment
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* Procedure: CTO coronary angioplasty
* Drug: Optimal medicamentous treatment
* Procedure: Stress-MRI


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress-MRI + Chronic total occlusion PCI<br>Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO | Procedure: CTO coronary angioplasty<br>* 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.<br>Procedure: Stress-MRI<br>* A standard stress-MRI test with adenosine<br>|
| Active Comparator: Stress-MRI + Optimal medicamentous treatment<br>Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment | Drug: Optimal medicamentous treatment<br> <br> Procedure: Stress-MRI<br>* A standard stress-MRI test with adenosine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Right coronary artery, Stress-MRI