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

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ClinicalTrials.gov Identifier: NCT01334931
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : May 9, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Exposure to Ionizing Radiation Occupational Exposure to Radiation Radiation Injury Radiation: Large field of view arm Radiation: Medium field of view Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : April 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. Patient's radiation exposure [ Time Frame: 24 hours ]
    Patient's radiation exposure will be measured in mGy at the end of procedure


Secondary Outcome Measures :
  1. Physician and nurse radiation exposure [ Time Frame: 24 hours ]
    Physician and nurse radiation exposure will be measured in microSv at the end of procedure


Eligibility Criteria

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334931


Locations
Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, RS, Brazil
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Investigators
Study Chair: Cristiano O Cardoso, MD, MSc Instituto de Cardiologia do Rio Grande do Sul
More Information

Responsible Party: Cristiano de Oliveira Cardoso, MD, MSc, Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01334931     History of Changes
Other Study ID Numbers: UP 4454/10
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Cristiano de Oliveira Cardoso, Instituto de Cardiologia do Rio Grande do Sul:
Exposure to Ionizing Radiation
Occupational Exposure to Radiation

Additional relevant MeSH terms:
Radiation Injuries
Wounds and Injuries