Use of Large Field of View During Image Acquisition for Coronary Angiography
XRay Reduction
Preferential Use of Large Field of View During Image Acquisition for Coronary Angiography With Flat Detector Technology: a Simple Step to Reduce Radiation Exposure
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 5, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMay 9, 2012
May 1, 2012
11 months
April 5, 2011
May 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient's radiation exposure
Patient's radiation exposure will be measured in mGy at the end of procedure
24 hours
Secondary Outcomes (1)
Physician and nurse radiation exposure
24 hours
Study Arms (2)
Large field of view
EXPERIMENTALPatients will have coronary angiography performed with large field of view lens
Medium field of view
ACTIVE COMPARATORPatients will have coronary angiography performed with medium field of view lens
Interventions
Patients will be allocated in the large field of view arm. Coronary angiography will be performed with large field of view lens (25 cm)
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 Criteria
You may qualify if:
- Indication of diagnostic coronary angiography for suspected coronary artery disease
- Sign written consent form
You may not qualify if:
- Therapeutics procedures
- Urgency/emergency procedures
- Previous CABG
- Severe valvular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cristiano O Cardoso, MD, MSc
Instituto de Cardiologia do Rio Grande do Sul
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc
Study Record Dates
First Submitted
April 5, 2011
First Posted
April 13, 2011
Study Start
April 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
May 9, 2012
Record last verified: 2012-05