Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

Not Applicable

Withdrawn

• Conditions: Angina Pectoris; Left Ventricular Wall Motion Abnormalities
• Interventions: Procedure: 2D-strain echo

• Registration Number: NCT01389674
• Lead Sponsor: RWTH Aachen University

Brief Summary

The investigators will check the feasibility of an intraprocedural vitality diagnostics and the identification of an indication for Percutaneous transluminal coronary angioplasty (PTCA).

Detailed Description

After myocard vitality diagnostics with MRI patients will underwent additionally an stress echocardiography within the exploration. By this ultrasound we will measure the LV mass and the ejection fraction per apical 2-, 3- and 4-chamber view.

In addition a 2D-strain-analysis will be done to measure the systolic and diastolic strain and also the circumferential and radial strain rate parameter (by depicting three parasternal short axis views in the basal, mid-ventricular and apical plane).

These measurements will be compared with the studies-conditioned MRI-finding (as reference) to find the optimal strain-parameter and the optimal cut-off-data for an intraprocedural vitality diagnostics of the single layers (endocardial, myocardial, and epicardial) for this patient group.

The data upraised through this are compared off-line to the MRI findings.

Study Timeline

• Study First Submitted: 2009-02-03
• Study Start: 2010-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-06
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• left ventricular wall motion abnormalities
• existent myocardial vitality MRI exploration
• reduced LV-function
• steady angina pectoris
• patients which are legally competent and which are mentally able to understand the study staff
• patients give their written consent

Exclusion Criteria

• pregnancy or lactation
• acute or instable angina pectoris
• acute myocardial infraction in the last 3 month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2D-strain echo	2D-strain echo	After myocard vitality diagnostics with MRI follows a stress echocardiography to determine the LV volumes and EF. The received Data are compare with the MRI-Data(reference)to identify the ideal strain-parameters and Cut-Off-Result for an intraprocedural vitality diagnostic of the different films (endocardial, myocardial and epicardial).

Primary Outcome Measures

Name	Time	Method
Cut-Off-Value of vital myocardial tissue	time during hospitalization	It will be determine cutt-off-value of vital myocardial tissue in comparison to MRI myocardial vitality findings.

Secondary Outcome Measures

Name	Time	Method
feasibility and safety of echocardiography during catheter investigations	time during hospitalization and 1 months afterwards	it will be analyzed if it is logistically possible to perform echo-test during the actual catheter investigations (feasibility) and if the patient will be exposed to any safety risk for logistic or sterility reasons.
Determination of Strain-Parameter for identification of vital myocardial tissue	time during hospitalization	It will be determitated optimal Strain-Parameter(circumferential, systolic or diastolic)for identification of vital myocardial tissue

Trial Locations

Locations (1)

University Hospital Aachen; 🇩🇪 Aachen, Germany