Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods
NCT ID: NCT01934699
Last Updated: 2015-09-23
Study Results
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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UNKNOWN
NA
130 participants
INTERVENTIONAL
2011-06-30
2016-07-31
Brief Summary
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Detailed Description
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* First Group: Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of this echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI (Percutaneous Coronary Intervention) will be performed.
* Second Group: Coronary angiography by patient will be canceled. Patients will get viability assessment using MRI(Magnetic resonance imaging) within the next 7 days. When vitality will be established with MRI, patient will get PCI (Percutaneous Coronary Intervention).
In addition, as part of a feasibility analysis, the possibility of a consolidation of data of coronary angiography with the ultrasound images will be researched by first group of patients. The aim is to simplify the visualization of the intraprocedural vitality detection. For this purpose, a position sensor based on electromagnetic fields (EMT) will be used during coronary angiography.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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MRI-Arm
Myocardial vitality determination based on MRI diagnostics.
MRI scanner
Coronary angiography on patient will be canceled. Patients will get viability assessment using MRI within the next 7 days. When vitality will be established with MRI, patient will get PCI.
Echo-Arm
Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis.
Cardiac ultrasound
Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of these echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI will be performed.
Interventions
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Cardiac ultrasound
Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of these echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI will be performed.
MRI scanner
Coronary angiography on patient will be canceled. Patients will get viability assessment using MRI within the next 7 days. When vitality will be established with MRI, patient will get PCI.
Eligibility Criteria
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Inclusion Criteria
* Echocardiographic determination of regional motion disfunction of left ventricular wall
* Establishment of needly treatment of stenosis related to motion disorder based on coronar angiography.
* Feasibility of MRI-Examination.
* Patients which are legally competent and which are mentally able to understand the study staff
* Patients give their written consent
Exclusion Criteria
* Patients with limited renal function(GFR \< 60 ml/min)
* Acute or instable angina pectoris
18 Years
90 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Michael Becker, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Aachen
Locations
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University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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00012377
Identifier Type: OTHER
Identifier Source: secondary_id
10-004
Identifier Type: -
Identifier Source: org_study_id
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