search
Back to results

Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

Primary Purpose

Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
CTO coronary angioplasty
Optimal medicamentous treatment
Stress-MRI
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Heart Disease focused on measuring Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Right coronary artery, Stress-MRI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • State Research Institute of CIrculation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stress-MRI + Chronic total occlusion PCI

Stress-MRI + Optimal medicamentous treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Clinical assessment
Dynamical assessment of stable angina FC (CCS) and dyspnea FC (NYHA)
Stress-MRI evaluation (2)
Dynamics of perfusion in myocardium scar tissue according to stress-MRI data
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.

Full Information

First Posted
May 8, 2016
Last Updated
May 15, 2016
Sponsor
Meshalkin Research Institute of Pathology of Circulation
search

1. Study Identification

Unique Protocol Identification Number
NCT02769650
Brief Title
Stress-MRI Assessment After Right Coronary Artery CTO Recanalization
Official Title
Clinical Significance of Stress-MRI Evaluation of Right Coronary Artery Chronic Total Occlusion Recanalization Efficacy in Patients With Coronary Artery Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease, Coronary Artery Stenosis
Keywords
Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Right coronary artery, Stress-MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress-MRI + Chronic total occlusion PCI
Arm Type
Experimental
Arm Description
Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO
Arm Title
Stress-MRI + Optimal medicamentous treatment
Arm Type
Active Comparator
Arm Description
Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment
Intervention Type
Procedure
Intervention Name(s)
CTO coronary angioplasty
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Optimal medicamentous treatment
Intervention Type
Procedure
Intervention Name(s)
Stress-MRI
Intervention Description
A standard stress-MRI test with adenosine
Primary Outcome Measure Information:
Title
Stress-MRI evaluation
Description
High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)
Time Frame
Within 2 and 12 month after hospitalization
Secondary Outcome Measure Information:
Title
Clinical assessment
Description
Dynamical assessment of stable angina FC (CCS) and dyspnea FC (NYHA)
Time Frame
Within 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 moths after hospitalization
Title
Stress-MRI evaluation (2)
Description
Dynamics of perfusion in myocardium scar tissue according to stress-MRI data
Time Frame
Within 2 and 12 month after hospitalization
Title
Major adverse cardiac and cerebrovascular events (MACCE)
Description
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.
Time Frame
During 1 year after first stress-MRI assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

We'll reach out to this number within 24 hrs