- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01310517
Hand Injected Ventriculography vs. Power Injected Left Ventriculography
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 Overview
Status
Conditions
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. (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
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients greater than 18 years of age referred for radial coronary angiography with left ventriculography for clinical indications at the Loma Linda Heart and Surgical Hospital or the Loma Linda University Medical Center will be included in this study.
Exclusion Criteria:
- Patients with a prosthetic aortic valve
- Patients with severe aortic stenosis
- Patients with suspected left main coronary artery disease
- Patients with other contraindications to left ventriculography.
- Patients with chronic kidney disease with a baseline creatinine ≥2.0 mg/dl if not already on renal replacement therapy will also be excluded
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Radial Coronary Angiography
The subjects enrolled in this study will be adults referred for radial coronary angiography with left ventriculography for clinical indications.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Imaging comparison
Time Frame: End of study
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End of study
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anthony A Hilliard, MD, Loma Linda University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HLVG2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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