Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography

NCT01605045 | Completed Phase 4 DMC

• 1 other identifier: S12-00007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Cardiac catheterization; Radiation

Outcome Measures

Primary Outcomes (1)

• 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.

  During coronary angiography

Secondary Outcomes (3)

• Dose area product from coronary angiography system

  During coronary angiography

• Quality of angiograms

• 30-day events

  30 days post-procedure

Study Arms (2)

Fluoroscopy-save group

EXPERIMENTAL

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

Standard technique

ACTIVE COMPARATOR

Coronary anatomy visualized and documented using cinematography alone (standard technique)

Other: Standard technique

Interventions

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)

Fluoroscopy-save group

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)

Standard technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• James Slater, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiac Catheterization Laboratory

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 24, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

US (1)