Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Completed

CT.gov ID

NCT02769650

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Coronary Atherosclerosis Coronary Artery Disease Coronary Artery Stenosis	Procedure: CTO coronary angioplasty Drug: Optimal medicamentous treatment Procedure: Stress-MRI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Stress-MRI + Chronic total occlusion PCI

Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO

Procedure: CTO 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.

Procedure: Stress-MRI

A standard stress-MRI test with adenosine

Active Comparator: Stress-MRI + Optimal medicamentous treatment

Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment

Drug: Optimal medicamentous treatment

Procedure: Stress-MRI

A standard stress-MRI test with adenosine

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)