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Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

This study is currently recruiting participants.
Verified May 2013 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01389674
First received: February 3, 2009
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention
Angina Pectoris
Left Ventricular Wall Motion Abnormalities
 Procedure: 2D-strain echo

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Hybrid Intraprocedural Imaging From 2D-Strain-echocardiography and X-ray Based Biplane Coronary Angiography for Guiding Interventional Revascularization Therapy

Resource links provided by NLM:

MedlinePlus related topics: Angina
U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Cut-Off-Value of vital myocardial tissue [ Time Frame: time during hospitalization ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: time during hospitalization and 1 months afterwards ] [ Designated as safety issue: Yes ]
    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 Frame: time during hospitalization ] [ Designated as safety issue: Yes ]
    It will be determitated optimal Strain-Parameter(circumferential, systolic or diastolic)for identification of vital myocardial tissue


Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389674

Contacts
Contact: Michael Becker, MD 004924180 ext 80092 mibecker@ukaachen.de

Locations
Germany
University Hospital Aachen Recruiting
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Michael Becker, MD RWTH Aachen University
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01389674     History of Changes
Other Study ID Numbers: HIB-Study, CTC-A 08-001, EK 079/10
Study First Received: February 3, 2009
Last Updated: May 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
coronary stenosis
Angina pectoris
left ventricular wall motion abnormalities

Additional relevant MeSH terms:
Congenital Abnormalities
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013