Clinical trial NCT01934699: Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods
Official title: Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Angina Pectoris
Left Ventricular Wall Motion Abnormalities
Keywords: Coronary stenosis
Angina pectoris
Left ventricular wall motion abnormalities
2D-Strain
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: State of health score
timeFrame: 6 month after diagnistics
Secondary outcomes:
measure: Left ventricular function (ejection function)
timeFrame: 6 month after diagnistics
measure: End-diastolic and end-systolic volume.
timeFrame: 6 month after diagnostics
measure: Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)
timeFrame: 18 month after diagnostics
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
state: NRW
Study officials:
affiliation: University Hospital, Aachen
name: Michael Becker, MD
role: PRINCIPAL_INVESTIGATOR
References: