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

May 7, 2012 updated by: Cristiano de Oliveira Cardoso, Instituto de Cardiologia do Rio Grande do Sul

Preferential Use of Large Field of View During Image Acquisition for Coronary Angiography With Flat Detector Technology: a Simple Step to Reduce Radiation Exposure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

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

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil
        • Instituto de Cardiologia do Rio Grande do Sul

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Large field of view
Patients will have coronary angiography performed with large field of view lens
Radiation: Large field of view arm
Patients will be allocated in the large field of view arm. Coronary angiography will be performed with large field of view lens (25 cm)
Active Comparator: Medium field of view
Patients will have coronary angiography performed with medium field of view lens
Radiation: Medium field of view
Patients will be allocated in the medium field of view arm. Coronary angiography will be performed with medium field of view lens (20 cm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's radiation exposure
Time Frame: 24 hours
Patient's radiation exposure will be measured in mGy at the end of procedure
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician and nurse radiation exposure
Time Frame: 24 hours
Physician and nurse radiation exposure will be measured in microSv at the end of procedure
24 hours

Collaborators and Investigators

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

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

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, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Estimate)

May 9, 2012

Last Update Submitted That Met QC Criteria

May 7, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP 4454/10

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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