Hand Injected Ventriculography vs. Power Injected Left Ventriculography
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|ClinicalTrials.gov Identifier: NCT01310517|
Recruitment Status : Terminated (Study was stopped due to low enrollment.)
First Posted : March 8, 2011
Last Update Posted : October 2, 2014
|Condition or disease|
|Heart; Functional Disturbance|
Left ventriculography is a routine and accurate method of evaluating left ventricular ejection fraction (EF) at the time of coronary angiography. Power injected left ventriculography (Power LV) using standard volume (36 ml over 3 seconds) of contrast through a 5 Fr. angled pigtail catheter in the left ventricle is currently a routine clinical practice during left heart catheterization via the radial artery. With coronary angiography from the radial approach increasing in popularity there is a growing interest in hand injected left ventriculography (Hand LV) using a very low volume (8ml) of contrast through a 5 Fr. radial angiographic catheter. Potential benefits of this method include reduced contrast load, reduced procedure time and overall reduction in cost (less catheters used per procedure) as the procedure can be completed using a single diagnostic catheter. Potential limitations of this method include reduced opacification of the left ventricle and decreased number of cardiac cycles available to estimate EF. It is currently unknown if Hand LV is accurate in estimating EF when compared to the standard Power LV.
Objective: The primary objective of this study is to directly compare the accuracy of the very low volume Hand LV to the standard volume Power LV in estimating EF.
Methods: This study will be conducted in an outpatient setting. The subjects enrolled in this study will be adults referred for radial coronary angiography with left ventriculography for clinical indications. Subjects will undergo both Hand LV and Power LV at the time of angiography. EF for both Hand LV and Power LV will be estimated for each subject in a blinded fashion by 2 independent experienced cardiologists. Additionally, quantitative EF measurements will be made using integrated standard computer software for both the Power LV and the Hand LV. Each patient will serve as their own control.
Research Design: This is a prospective single center study designed to evaluate clinical techniques for diagnostic accuracy.
Clinical Relationships: It is anticipated that Hand LV will be and accurate method to estimate EF when compared to Power LV. (e.g. within a 5% difference is clinically is considered within inter and intra-individual variability.) This knowledge will allow clinicians to confidently perform Hand LV at the time of radial coronary angiography to estimate EF, reducing procedure time, contrast load and overall cost of the procedure.
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Comparison of Very Low Contrast Volume Hand Injected Ventriculography to Standard Contrast Volume Power Injected Left Ventriculography From the Radial Artery Approach for Estimation of Left Ventricular Ejection Fraction.|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Radial Coronary Angiography
The subjects enrolled in this study will be adults referred for radial coronary angiography with left ventriculography for clinical indications.
- Imaging comparison [ Time Frame: End of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310517
|United States, California|
|Loma Linda University Medical Center|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||Anthony A Hilliard, MD||Loma Linda University Medical Center|