Overview

This trial is active, not recruiting.

Conditions angina pectoris, left ventricular wall motion abnormalities
Treatments cardiac ultrasound, mri scanner
Sponsor RWTH Aachen University
Start date June 2011
End date May 2016
Trial size 130 participants
Trial identifier NCT01934699, 00012377, 10-004

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
Myocardial vitality determination based on MRI diagnostics.
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.
(Experimental)
Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis.
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.

Primary Outcomes

Measure
State of health score
time frame: 6 month after diagnistics

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics
Principal investigator Michael Becker, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by RWTH Aachen University.