Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography

October 11, 2012 updated by: James Slater, NYU Langone Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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)
Active Comparator: Standard technique
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of radiation exposure to the patient
Time Frame: During coronary angiography
Surface peak skin dose, as measured by the Gafchromic XR RV3 film strip, which is placed under the patient's back during the procedure.
During coronary angiography

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose area product from coronary angiography system
Time Frame: During coronary angiography
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
30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: James Slater, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 22, 2012

First Posted (Estimate)

May 24, 2012

Study Record Updates

Last Update Posted (Estimate)

October 15, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S12-00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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