Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Coronary Atherosclerosis; Coronary Artery Stenosis
• Intervention / Treatment: Procedure: CTO coronary angioplasty; Procedure: Stress-MRI; Drug: Optimal medicamentous treatment

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • State Research Institute of Circulation Pathology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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	Procedure: Stress-MRI; A standard stress-MRI test with adenosine; Drug: Optimal medicamentous treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 8, 2016
• First Submitted That Met QC Criteria: May 8, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 15, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Ischemic Heart Disease; Drug-eluting stent; Chronic total occlusion; Coronary stenosis; Coronary angioplasty with stenting; Right coronary artery; Stress-MRI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis; Coronary Stenosis
• Other Study ID Numbers: Stress-MRI 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No