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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
Sponsor:
Information provided by (Responsible Party):
Anthony Hilliard, Loma Linda University

Study Description
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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.

Condition or disease
Heart; Functional Disturbance

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 Design
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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Groups and Cohorts
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Group/Cohort
Radial Coronary Angiography
The subjects enrolled in this study will be adults referred for radial coronary angiography with left ventriculography for clinical indications.


Outcome Measures
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Primary Outcome Measures :
  1. Imaging comparison [ Time Frame: End of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects enrolled in this study will be adults referred for radial coronary angiography with left ventriculography for clinical indications.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Anthony A Hilliard, MD Loma Linda University Medical Center
More Information
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Responsible Party: Anthony Hilliard, Cardiology, Loma Linda University
ClinicalTrials.gov Identifier: NCT01310517     History of Changes
Other Study ID Numbers: HLVG2011
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: October 2014

Keywords provided by Anthony Hilliard, Loma Linda University:
Angiogram
Injected Contrast
Heart Function
contrast dye

Additional relevant MeSH terms:
Pathologic Processes