Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01389674
• Other study ID #: HIB-Study
• Secondary ID: CTC-A 08-001EK 0
• Status: Withdrawn
• Phase: N/A
• First received: February 3, 2009
• Last updated: June 6, 2014
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2014
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Angina Pectoris
• Congenital Abnormalities
• Left Ventricular Wall Motion Abnormalities

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes