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Completed

NCT Number: NCT01605045

Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluoroscopy-save group

Other

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)

Standard technique

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. Dose area product from coronary angiography system

    Time frame: During coronary angiography

  2. 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.

  3. 30-day events

    Time frame: 30 days post-procedure

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Efficacy of Fluoroscopy-save Function During Cardiac Catheterization

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 24, 2012
Registry last updated
Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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