NCT01334931

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

Enrollment Period

11 months

First QC Date

April 5, 2011

Last Update Submit

May 7, 2012

Conditions

Keywords

Exposure to Ionizing RadiationOccupational Exposure to Radiation

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

EXPERIMENTAL

Patients will have coronary angiography performed with large field of view lens

Radiation: Large field of view arm

Medium field of view

ACTIVE COMPARATOR

Patients will have coronary angiography performed with medium field of view lens

Radiation: Medium field of view

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)

Large 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)

Medium field of view

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Cristiano O Cardoso, MD, MSc

    Instituto de Cardiologia do Rio Grande do Sul

    STUDY CHAIR

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

Locations