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

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul (Other)
• Overall Status: Completed
• CT.gov ID: NCT01334931
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 10.9

Study Details

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
• 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: Apr 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

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 [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 [24 hours]

   Physician and nurse radiation exposure will be measured in microSv at the end of procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cristiano de Oliveira Cardoso, MD, MSc, Instituto de Cardiologia do Rio Grande do Sul
• ClinicalTrials.gov Identifier: NCT01334931
• Other Study ID Numbers: UP 4454/10
• First Posted: Apr 13, 2011
• Last Update Posted: May 9, 2012
• Last Verified: May 1, 2012

• Keywords provided by Cristiano de Oliveira Cardoso, MD, MSc, Instituto de Cardiologia do Rio Grande do Sul: Exposure to Ionizing Radiation; Occupational Exposure to Radiation
• Additional relevant MeSH terms: Radiation Injuries

Study Results

No Results Posted as of May 9, 2012