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

Radiation Injury Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334931
• Other study ID #: UP 4454/10
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2011
• Last updated: May 7, 2012
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exposure to Ionizing Radiation
• Occupational Exposure to Radiation
• Radiation Injuries
• Radiation Injury

Intervention

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)
• 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)

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia do Rio Grande do Sul	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's radiation exposure	Patient's radiation exposure will be measured in mGy at the end of procedure	24 hours	Yes
Secondary	Physician and nurse radiation exposure	Physician and nurse radiation exposure will be measured in microSv at the end of procedure	24 hours	Yes