Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01934699
First received: August 29, 2013
Last updated: April 29, 2014
Last verified: April 2014

August 29, 2013
April 29, 2014
June 2011
June 2016   (final data collection date for primary outcome measure)
State of health score [ Time Frame: 6 month after diagnistics ] [ Designated as safety issue: Yes ]
State of health score will be determinated by all patients for the evaluation of clinical outcomes (using the standardized questionnaire on state of health (SF-36))6 months after clinical diagnostics.
Same as current
Complete list of historical versions of study NCT01934699 on ClinicalTrials.gov Archive Site
  • Left ventricular function (ejection function) [ Time Frame: 6 month after diagnistics ] [ Designated as safety issue: Yes ]
    Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.
  • End-diastolic and end-systolic volume. [ Time Frame: 6 month after diagnostics ] [ Designated as safety issue: Yes ]
    End-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics
  • Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE) [ Time Frame: 18 month after diagnostics ] [ Designated as safety issue: Yes ]
    It will be determined, whether all patients suffered any major adverse cardiac and cerebrovascular events (MACCE) inter alia stroke, myocardial infarction, death 18 month after diagnostics
Same as current
Not Provided
Not Provided
 
Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods
Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Angina Pectoris
  • Left Ventricular Wall Motion Abnormalities
  • Device: 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.
  • 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.
  • Active Comparator: MRI-Arm
    Myocardial vitality determination based on MRI diagnostics.
    Intervention: Device: MRI scanner
  • Experimental: Echo-Arm
    Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis.
    Intervention: Device: Cardiac ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Michael Becker, MD 004924180 ext 80092
Contact: Margarita Gritzewski mgritzewski@ukaachen.de
Germany
 
NCT01934699
10-004, 00012377
No
RWTH Aachen University
RWTH Aachen University
Not Provided
Principal Investigator: Michael Becker, MD University Hospital, Aachen
RWTH Aachen University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP