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Trial record 39 of 172 for:    "Heart Disease" | "Heparin"

Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

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ClinicalTrials.gov Identifier: NCT02769650
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Coronary Atherosclerosis Coronary Artery Disease Coronary Artery Stenosis Procedure: CTO coronary angioplasty Drug: Optimal medicamentous treatment Procedure: Stress-MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Significance of Stress-MRI Evaluation of Right Coronary Artery Chronic Total Occlusion Recanalization Efficacy in Patients With Coronary Artery Disease.
Study Start Date : October 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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
Drug: Optimal medicamentous treatment
Procedure: Stress-MRI
A standard stress-MRI test with adenosine




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769650


Locations
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Russian Federation
State Research Institute of CIrculation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02769650     History of Changes
Other Study ID Numbers: Stress-MRI 1.0
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Coronary stenosis
Drug-eluting stent
Coronary angioplasty with stenting
Ischemic Heart Disease
Chronic total occlusion
Right coronary artery
Stress-MRI
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Atherosclerosis
Coronary Stenosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases