Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

NCT ID: NCT01934699

Last Updated: 2015-09-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-07-31

Brief Summary

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The investigators will compare myocard vitality diagnostics using 2D-Strain echography and MRI.

Detailed Description

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Each patient with typical angina pectoris symptoms will get echocardiographic examination during the inclusion phase. If motion disorder of regional left ventricular myocardial wall is detected, patient will get coronary angiography (not study related, caused of typical angina pectoris symptoms and high probability of CHD). If coronary stenosis related to motion disorder is available, patient will be randomized in two groups during coronary angiography.

* 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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Angina Pectoris Left Ventricular Wall Motion Abnormalities

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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MRI-Arm

Myocardial vitality determination based on MRI diagnostics.

Group Type ACTIVE_COMPARATOR

MRI scanner

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Cardiac ultrasound

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Typical angina pectoris symptoms
* 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

* Allergy against contrast agent
* Patients with limited renal function(GFR \< 60 ml/min)
* Acute or instable angina pectoris
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

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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