Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

RWTH Aachen University

Status: Unknown

Conditions: Left Ventricular Wall Motion Abnormalities; Angina Pectoris

Treatments: Device: Cardiac ultrasound; Device: MRI scanner

Study type: Interventional

Funder types: Other

Identifiers

NCT01934699

00012377 (Other Identifier)

10-004

Details and patient eligibility

About

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

Full description

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

MRI-Arm

Active Comparator group

Description:

Myocardial vitality determination based on MRI diagnostics.

Treatment:

Device: MRI scanner

Echo-Arm

Experimental group

Description:

Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis.

Treatment:

Device: Cardiac ultrasound