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Completed

NCT Number: NCT02769650

Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

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.

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Key information

Conditions

Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Artery Stenosis Coronary Atherosclerosis Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CTO coronary angioplasty

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.

Optimal medicamentous treatment

Drug

stress-MRI

Procedure

A standard stress-MRI test with adenosine

Primary outcomes

  1. Stress-MRI evaluation

    Time frame: 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 outcomes

  1. Clinical assessment

    Time frame: 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)

  2. Stress-MRI evaluation (2)

    Time frame: Within 2 and 12 month after hospitalization

    Dynamics of perfusion in myocardium scar tissue according to stress-MRI data

  3. Major adverse cardiac and cerebrovascular events (MACCE)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 11, 2016
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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