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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01389674
Enrollment
0
Registered
2011-07-08
Start date
2010-04-30
Completion date
2011-06-30
Last updated
2014-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Left Ventricular Wall Motion Abnormalities

Keywords

coronary stenosis, Angina pectoris, left ventricular wall motion abnormalities

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.

Interventions

PROCEDURE2D-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.

Sponsors

RWTH Aachen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cut-Off-Value of vital myocardial tissuetime during hospitalizationIt will be determine cutt-off-value of vital myocardial tissue in comparison to MRI myocardial vitality findings.

Secondary

MeasureTime frameDescription
feasibility and safety of echocardiography during catheter investigationstime during hospitalization and 1 months afterwardsit 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 tissuetime during hospitalizationIt will be determitated optimal Strain-Parameter(circumferential, systolic or diastolic)for identification of vital myocardial tissue

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026