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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
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 Coronary anatomy visualized and documented using cinematography alone (standard technique)
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 Coronary anatomy visualized and documented using cinematography alone (standard technique)
New York University School of Medicine
New York, New York, United States
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.
Time frame: During coronary angiography
Dose area product from coronary angiography system
Time frame: During coronary angiography
Quality of angiograms
One extra picture will be taken at random using the mode that the study was not randomized to. 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 and degree of correlation between the fluoroscopy-save picture and cinematography picture will be recorded.
30-day events
Time frame: 30 days post-procedure
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