Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

Hybrid Intraprocedural Imaging From 2D-Strain-echocardiography and X-ray Based Biplane Coronary Angiography for Guiding Interventional Revascularization Therapy

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

Study Overview

• Status: Withdrawn
• Conditions: Angina Pectoris; Left Ventricular Wall Motion Abnormalities
• Intervention / Treatment: Procedure: 2D-strain echo

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • University Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: 2D-strain echo; 2D-strain-analysis with elevation of the radial and circumferential strain and strain rate parameter(systolic and diastolic)occurs through the echocardiography. Comparison of the echocardiography and the MRI-vitality data, calculation of a cut out of vision value of a vitality diagnosis with the help of 2D-strain-analysis.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility and safety of echocardiography during catheter investigations	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.	time during hospitalization and 1 months afterwards
Determination of Strain-Parameter for identification of vital myocardial tissue	It will be determitated optimal Strain-Parameter(circumferential, systolic or diastolic)for identification of vital myocardial tissue	time during hospitalization

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Michael Becker, MD, RWTH Aachen University

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Estimate): June 9, 2014
• Last Update Submitted That Met QC Criteria: June 6, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Angina pectoris; coronary stenosis; left ventricular wall motion abnormalities
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Congenital Abnormalities; Angina Pectoris
• Other Study ID Numbers: HIB-Study; CTC-A 08-001; EK 079/10