Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

Not Applicable

Completed

• Conditions: Ischemic Heart Disease; Coronary Artery Disease; Coronary Atherosclerosis; Coronary Artery Stenosis
• Interventions: Procedure: CTO coronary angioplasty; Drug: Optimal medicamentous treatment; Procedure: Stress-MRI

• Registration Number: NCT02769650
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-08
• Study First Submitted QC: 2016-05-08
• Study First Posted: 2016-05-11
• Last Update Submitted: 2016-05-15
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress-MRI + Chronic total occlusion PCI	CTO coronary angioplasty	Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO
Stress-MRI + Chronic total occlusion PCI	Stress-MRI	Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO
Stress-MRI + Optimal medicamentous treatment	Optimal medicamentous treatment	Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment
Stress-MRI + Optimal medicamentous treatment	Stress-MRI	Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Stress-MRI evaluation (2)	Within 2 and 12 month after hospitalization	Dynamics of perfusion in myocardium scar tissue according to stress-MRI data
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)

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology; 🇷🇺 Novosibirsk, Russian Federation