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Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention

Primary Purpose

Stable Angina, Unstable Angina, Acute Coronary Syndrome

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

15 FPS

7.5 FPS

About this trial

This is an interventional health services research trial for Stable Angina focused on measuring fluoroscopy, radiation, transradial, diagnostic, angiography, cardiac, coronary, angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients undergoing elective, urgent or emergent cardiac catheterization procedures with or without ad hoc PCI, via transradial approach are eligible.

Exclusion Criteria:

1) non-transradial access and 2) participation in research project(s) requiring higher ie 30 FPS cine angiography.

Sites / Locations

IUCPQ - Laval Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

7.5 FPS

15 FPS

Arm Description

Low rate fluoroscopy at 7.5 frames per second (FPS)

Conventional rate fluoroscopy at 15 FPS

Outcomes

Primary Outcome Measures

Radiation Exposure

Operator radiation dose (measured with dosimeter attached to the left side of thyroid shield, in µSv)

Radiation Exposure

Patient radiation dose (expressed as dose-area product [DAP] in μGy.m2)

Radiation Exposure

Fluoroscopy time

Secondary Outcome Measures

Procedural Characteristics

Procedural duration

Procedural Characteristics

Total contrast volume used

Full Information

NCT ID

NCT01990924

First Posted

November 7, 2013

Last Updated

November 18, 2013

Sponsor

Laval University

1. Study Identification

Unique Protocol Identification Number

NCT01990924

Brief Title

Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention

Official Title

Low Rate Fluoroscopy at Reducing Operator and Patient Radiation Dose During Transradial Coronary Diagnostic Angiography and Interventions

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Objectives: To determine the efficacy of low rate fluoroscopy at 7.5 frames per second (FPS) vs. conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography and percutaneous coronary intervention via the transradial approach. Background: Transradial approach for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has potential to reduce radiation exposure.

Detailed Description

Methods: Patients undergoing transradial approach diagnostic angiography ± ad hoc PCI, wil be randomized to fluoroscopy at 7.5 FPS vs. 15 FPS prior to procedure. Both 7.5 and 15 FPS fluoroscopy protocols will be configured with a fixed dose per pulse of 40 nGy. Primary endpoints will be operator radiation dose (measured with dosimeter attached to the left side of thyroid shield in µSv), patient radiation dose (expressed as dose-area product in μGy.m2), and fluoroscopy time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stable Angina, Unstable Angina, Acute Coronary Syndrome

Keywords

fluoroscopy, radiation, transradial, diagnostic, angiography, cardiac, coronary, angioplasty

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

385 (Actual)

8. Arms, Groups, and Interventions

Arm Title

7.5 FPS

Arm Type

Experimental

Arm Description

Low rate fluoroscopy at 7.5 frames per second (FPS)

Arm Title

15 FPS

Arm Type

Active Comparator

Arm Description

Conventional rate fluoroscopy at 15 FPS

Intervention Type

Radiation

Intervention Name(s)

15 FPS

Other Intervention Name(s)

Standard practice, conventional 15 frames per second (FPS)

Intervention Description

X-ray pictures

Intervention Type

Radiation

Intervention Name(s)

7.5 FPS

Other Intervention Name(s)

Low rate fluoroscopy at 7.5 FPS

Intervention Description

X-ray pictures

Primary Outcome Measure Information:

Title

Radiation Exposure

Description

Operator radiation dose (measured with dosimeter attached to the left side of thyroid shield, in µSv)

Time Frame

During Cardiac Catheterization

Title

Radiation Exposure

Description

Patient radiation dose (expressed as dose-area product [DAP] in μGy.m2)

Time Frame

During Cardiac Catheterization

Title

Radiation Exposure

Description

Fluoroscopy time

Time Frame

During Cardiac Catheterization

Secondary Outcome Measure Information:

Title

Procedural Characteristics

Description

Procedural duration

Time Frame

During Cardiac Catheterization

Title

Procedural Characteristics

Description

Total contrast volume used

Time Frame

During Cardiac Catheterization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients undergoing elective, urgent or emergent cardiac catheterization procedures with or without ad hoc PCI, via transradial approach are eligible. Exclusion Criteria: 1) non-transradial access and 2) participation in research project(s) requiring higher ie 30 FPS cine angiography.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olivier F Bertrand, MD PhD

Organizational Affiliation

International Chair on Interventional Cardiology and Transradial Approach

Official's Role

Study Chair

Facility Information:

Facility Name

IUCPQ - Laval Hospital

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24746649

Citation

Abdelaal E, Plourde G, MacHaalany J, Arsenault J, Rimac G, Dery JP, Barbeau G, Larose E, De Larochelliere R, Nguyen CM, Allende R, Ribeiro H, Costerousse O, Mongrain R, Bertrand OF; Interventional Cardiologists at Quebec Heart-Lung Institute. Effectiveness of low rate fluoroscopy at reducing operator and patient radiation dose during transradial coronary angiography and interventions. JACC Cardiovasc Interv. 2014 May;7(5):567-74. doi: 10.1016/j.jcin.2014.02.005. Epub 2014 Apr 16.

Results Reference

derived

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Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention

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