Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography - Full Text View

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Other: Fluoroscopy-save group Other: Standard technique	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Efficacy of Fluoroscopy-save Function During Cardiac Catheterization

Resource links provided by NLM:

MedlinePlus related topics: Anatomy Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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 ]

Enrollment:	50
Study Start Date:	April 2012
Study Completion Date:	September 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605045

Locations

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

Sponsors and Collaborators

New York University School of Medicine

Investigators

Principal Investigator:

James Slater, MD

New York University School of Medicine

More Information

No publications provided

Responsible Party:	James Slater, Director of Cardiac Catheterization Laboratory, New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01605045 History of Changes
Other Study ID Numbers:	S12-00007
Study First Received:	May 10, 2012
Last Updated:	October 11, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

Cardiac catheterization
Radiation

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013