Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Slater, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01605045
First received: May 10, 2012
Last updated: October 11, 2012
Last verified: October 2012

May 10, 2012
October 11, 2012
April 2012
August 2012   (final data collection date for primary outcome measure)
Measure of radiation exposure to the patient [ Time Frame: During coronary angiography ] [ Designated as safety issue: No ]
Surface peak skin dose, as measured by the Gafchromic XR RV3 film strip, which is placed under the patient's back during the procedure.
Same as current
Complete list of historical versions of study NCT01605045 on ClinicalTrials.gov Archive Site
  • Dose area product from coronary angiography system [ Time Frame: During coronary angiography ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
  • Other: Fluoroscopy-save group
    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)
  • Other: 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)
  • Experimental: Fluoroscopy-save group
    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
    Intervention: Other: Fluoroscopy-save group
  • Active Comparator: Standard technique
    Coronary anatomy visualized and documented using cinematography alone (standard technique)
    Intervention: Other: Standard technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01605045
S12-00007
Yes
James Slater, New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: James Slater, MD New York University School of Medicine
New York University School of Medicine
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP