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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01934699
Enrollment
130
Registered
2013-09-04
Start date
2011-06-30
Completion date
2016-07-31
Last updated
2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Left Ventricular Wall Motion Abnormalities

Keywords

Coronary stenosis, Angina pectoris, Left ventricular wall motion abnormalities, 2D-Strain

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.

Interventions

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.

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.

Sponsors

RWTH Aachen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
State of health score6 month after diagnisticsState 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

MeasureTime frameDescription
Left ventricular function (ejection function)6 month after diagnisticsLeft ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.
End-diastolic and end-systolic volume.6 month after diagnosticsEnd-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics
Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)18 month after diagnosticsIt 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026