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Use of Large Field of View During Image Acquisition for Coronary Angiography (XRay Reduction)

Primary Purpose

Exposure to Ionizing Radiation, Occupational Exposure to Radiation, Radiation Injury

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Large field of view arm
Medium field of view
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exposure to Ionizing Radiation focused on measuring Exposure to Ionizing Radiation, Occupational Exposure to Radiation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication of diagnostic coronary angiography for suspected coronary artery disease
  • Sign written consent form

Exclusion Criteria:

  • Therapeutics procedures
  • Urgency/emergency procedures
  • Previous CABG
  • Severe valvular disease

Sites / Locations

  • Instituto de Cardiologia do Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Large field of view

Medium field of view

Arm Description

Patients will have coronary angiography performed with large field of view lens

Patients will have coronary angiography performed with medium field of view lens

Outcomes

Primary Outcome Measures

Patient's radiation exposure
Patient's radiation exposure will be measured in mGy at the end of procedure

Secondary Outcome Measures

Physician and nurse radiation exposure
Physician and nurse radiation exposure will be measured in microSv at the end of procedure

Full Information

First Posted
April 5, 2011
Last Updated
May 7, 2012
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT01334931
Brief Title
Use of Large Field of View During Image Acquisition for Coronary Angiography
Acronym
XRay Reduction
Official Title
Preferential Use of Large Field of View During Image Acquisition for Coronary Angiography With Flat Detector Technology: a Simple Step to Reduce Radiation Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of this study is to evaluate the routine use of large field of view during image acquisition for coronary angiography. Patients with indication of diagnostic coronary angiography will be randomized for the use of either large field of view during image acquisition or medium field of view. Patients, physician and nurse radiation exposure will be measured by digital dosimeter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exposure to Ionizing Radiation, Occupational Exposure to Radiation, Radiation Injury
Keywords
Exposure to Ionizing Radiation, Occupational Exposure to Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Large field of view
Arm Type
Experimental
Arm Description
Patients will have coronary angiography performed with large field of view lens
Arm Title
Medium field of view
Arm Type
Active Comparator
Arm Description
Patients will have coronary angiography performed with medium field of view lens
Intervention Type
Radiation
Intervention Name(s)
Large field of view arm
Intervention Description
Patients will be allocated in the large field of view arm. Coronary angiography will be performed with large field of view lens (25 cm)
Intervention Type
Radiation
Intervention Name(s)
Medium field of view
Intervention Description
Patients will be allocated in the medium field of view arm. Coronary angiography will be performed with medium field of view lens (20 cm)
Primary Outcome Measure Information:
Title
Patient's radiation exposure
Description
Patient's radiation exposure will be measured in mGy at the end of procedure
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Physician and nurse radiation exposure
Description
Physician and nurse radiation exposure will be measured in microSv at the end of procedure
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication of diagnostic coronary angiography for suspected coronary artery disease Sign written consent form Exclusion Criteria: Therapeutics procedures Urgency/emergency procedures Previous CABG Severe valvular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiano O Cardoso, MD, MSc
Organizational Affiliation
Instituto de Cardiologia do Rio Grande do Sul
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Cardiologia do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Use of Large Field of View During Image Acquisition for Coronary Angiography

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