Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

NCT ID: NCT01389674

Last Updated: 2014-06-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-06-30

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.

Conditions

Angina Pectoris; Left Ventricular Wall Motion Abnormalities

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

2D-strain echo

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Becker, MD

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University

Locations

University Hospital Aachen

Aachen, , Germany

Countries

Germany

Other Identifiers

CTC-A 08-001

Identifier Type: -

Identifier Source: secondary_id

EK 079/10

Identifier Type: -

Identifier Source: secondary_id

HIB-Study

Identifier Type: -

Identifier Source: org_study_id