Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

NCT ID: NCT02769650

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-04-30

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.

Detailed Description

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Conditions

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Ischemic Heart Disease Coronary Atherosclerosis Coronary Artery Disease Coronary Artery Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Stress-MRI + Chronic total occlusion PCI

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

Group Type EXPERIMENTAL

CTO coronary angioplasty

Intervention Type PROCEDURE

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.

Stress-MRI

Intervention Type PROCEDURE

A standard stress-MRI test with adenosine

Stress-MRI + Optimal medicamentous treatment

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

Group Type ACTIVE_COMPARATOR

Optimal medicamentous treatment

Intervention Type DRUG

Stress-MRI

Intervention Type PROCEDURE

A standard stress-MRI test with adenosine

Interventions

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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.

Intervention Type PROCEDURE

Optimal medicamentous treatment

Intervention Type DRUG

Stress-MRI

A standard stress-MRI test with adenosine

Intervention Type PROCEDURE

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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State Research Institute of CIrculation Pathology

Novosibirsk, , Russia

Site Status

Countries

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Russia

Other Identifiers

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Stress-MRI 1.0

Identifier Type: -

Identifier Source: org_study_id

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