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Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

Primary Purpose

Angina Pectoris, Left Ventricular Wall Motion Abnormalities

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
2D-strain echo
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Angina Pectoris focused on measuring coronary stenosis, Angina pectoris, left ventricular wall motion abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Aachen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

2D-strain echo

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
February 3, 2009
Last Updated
June 6, 2014
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01389674
Brief Title
Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods
Official Title
Hybrid Intraprocedural Imaging From 2D-Strain-echocardiography and X-ray Based Biplane Coronary Angiography for Guiding Interventional Revascularization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Left Ventricular Wall Motion Abnormalities
Keywords
coronary stenosis, Angina pectoris, left ventricular wall motion abnormalities

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2D-strain echo
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
2D-strain echo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cut-Off-Value of vital myocardial tissue
Description
It will be determine cutt-off-value of vital myocardial tissue in comparison to MRI myocardial vitality findings.
Time Frame
time during hospitalization
Secondary Outcome Measure Information:
Title
feasibility and safety of echocardiography during catheter investigations
Description
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 Frame
time during hospitalization and 1 months afterwards
Title
Determination of Strain-Parameter for identification of vital myocardial tissue
Description
It will be determitated optimal Strain-Parameter(circumferential, systolic or diastolic)for identification of vital myocardial tissue
Time Frame
time during hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Becker, MD
Organizational Affiliation
RWTH Aachen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

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