Ignite Creation Date:
2024-05-05 @ 11:22 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01310517
Status:
TERMINATED
Last Update Posted:
2014-10-02
First Post:
2011-03-07
Brief Title:
Hand Injected Ventriculography vs Power Injected Left Ventriculography
Sponsor:
Loma Linda University
Organization:
Loma Linda University
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was stopped due to low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to directly compare two methods of evaluating heart function at the time of your angiogram In both methods contrast dye is injected into the main heart chamber during the angiogram while x-ray images are taken One method uses an automatic power injector to deliver the normal volume of contrast the other method uses hand injection of very low volume of contrast into the main heart chamber It is hypothesized that hand injection will prove to be an accurate method to estimate ejection fraction EF at the time of radial coronary angiography when compared directly to Power LV
Detailed Description:
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None