Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluoroscopy-save group
Standard technique
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Cardiac catheterization, Radiation
Eligibility Criteria
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fluoroscopy-save group
Standard technique
Arm Description
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Dose area product from coronary angiography system
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01605045
Brief Title
Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography
Official Title
Efficacy of Fluoroscopy-save Function During Cardiac Catheterization
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Cardiac catheterization, Radiation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoroscopy-save group
Arm Type
Experimental
Arm Description
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
Arm Title
Standard technique
Arm Type
Active Comparator
Arm Description
Coronary anatomy visualized and documented using cinematography alone (standard technique)
Intervention Type
Other
Intervention Name(s)
Fluoroscopy-save group
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Standard technique
Intervention Description
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)
Primary Outcome Measure Information:
Title
Measure of radiation exposure to the patient
Description
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
Secondary Outcome Measure Information:
Title
Dose area product from coronary angiography system
Time Frame
During coronary angiography
Title
Quality of angiograms
Description
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.
Title
30-day events
Time Frame
30 days post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Slater, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography
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