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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cristiano de Oliveira Cardoso, Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01334931
First received: April 5, 2011
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:

Primary Outcome Measures:
  • Patient's radiation exposure [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Patient's radiation exposure will be measured in mGy at the end of procedure


Secondary Outcome Measures:
  • Physician and nurse radiation exposure [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Physician and nurse radiation exposure will be measured in microSv at the end of procedure


Enrollment: 120
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 5, 2011
Last Updated: May 7, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013