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Clinical Trials/NCT01934699
NCT01934699
Unknown
Not Applicable

Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics

RWTH Aachen University1 site in 1 country130 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Angina Pectoris
Sponsor
RWTH Aachen University
Enrollment
130
Locations
1
Primary Endpoint
State of health score
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
July 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

State of health score

Time Frame: 6 month after diagnistics

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.

Secondary Outcomes

  • Left ventricular function (ejection function)(6 month after diagnistics)
  • Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)(18 month after diagnostics)
  • End-diastolic and end-systolic volume.(6 month after diagnostics)

Study Sites (1)

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