Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:April 2012
End Date:July 2012
Contact:James Slater, MD
Email:james.slater@nyumc.org
Phone:212-263-5656

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Efficacy of Fluoroscopy-save Function During Cardiac Catheterization


The aim of this study is to evaluate the effects of screening using the fluoroscopy-save
function on reduction of radiation exposure and quality of angiogram during cardiac
catheterization when compared to traditional cinematography-guided coronary angiography.


The study will be a prospective, randomized study of patients undergoing
clinically-indicated coronary angiograpy in the New York University (NYU) Langone Medical
Center cardiac catheterization laboratory. Patients will be randomized to one of two
coronary angiography protocols: (1) Coronary anatomy visualized under fluoroscopy,
documented using the fluoroscopy-save function, and further visualized using cinematography
only when higher quality is necessary (fluoroscopy-save technique) versus (2) Coronary
anatomy visualized and documented using cinematography alone (standard technique). The
primary outcome will be a measure of radiation exposure to the patient, surface peak skin
dose, as measured by the Gafchromic XR RV3 film strip, which is placed under the patient's
back during the procedure. Other outcome measures will include radiation output recorded
by the fluoroscopy machine, amount of contrast used, and quality of angiograms performed. To
determine if the quality of the angiograms performed using the fluoroscopy-save technique is
non-inferior to the standard technique, one extra picture will be taken at random using the
mode that the study was not randomized to. For example, in the fluoroscopy-save group, a
picture that was not visualized under cinematography during the study will be repeated and
documented under cinematograpy. In the standard group, a picture will be repeated and
documented using the fluoroscopy-save function. These 2 pictures from each study will then
be collated and put together in no particular order with all identifiers removed. These
single pictures will be read by 2 interventional cardiologists not involved in the study in
a blinded fashion. The degree of coronary artery disease as determined by these 2 readers
will be compared between the fluoroscopy-save picture and cinematography picture.

Inclusion Criteria:

- Patients will be recruited from the cardiac catheterization laboratory at the NYU
Langone Medical Center.

- Patients will be eligible if they are more than 18 years of age and are referred for
coronary angiography.

Exclusion Criteria:

- Patients will be excluded if they have reduced renal function since they must receive
as minimal of contrast amount as possible, and if their abdominal circumference is >
45 inches since the quality of images under fluoroscopy alone is poorer in patients
with increased abdominal girth.
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