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Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors (EXPERT)

Primary Purpose

Exposure to Ionizing Radiation, Coronary Heart Disease, Vascular Access Complication

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Trans-radial
Trans-femoral
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exposure to Ionizing Radiation focused on measuring Occupational radiation exposure, Transradial approach, Transfemoral approach

Eligibility Criteria

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

Inclusion Criteria:

  • Indication for a elective coronary angiography
  • Eligible for either transfemoral or transradial approach
  • Accept to sign the written consent form (WCF)

Exclusion Criteria:

  • Refusal to sign the WCF
  • End stage renal failure
  • Urgency/Emergency procedure
  • Contraindication to perform both coronary and left ventricle angiogram
  • Necessity of another vascular angiogram during coronary angiography

Sites / Locations

  • Instituto de Cardiologia do Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trans-radial access

Trans-femoral access

Arm Description

Coronary angiography performed through trans-radial access

Coronary angiography performed through trans-femoral access

Outcomes

Primary Outcome Measures

Patient radiation exposure (mGy)
Patient radiation exposure (mGy)

Secondary Outcome Measures

Physician radiation exposure (in uSv)
Physician radiation exposure (in uSv)

Full Information

First Posted
February 15, 2013
Last Updated
September 16, 2014
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Hospital Ernesto Dornelles
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1. Study Identification

Unique Protocol Identification Number
NCT01794325
Brief Title
Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors
Acronym
EXPERT
Official Title
Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Hospital Ernesto Dornelles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Transradial approach (TRA) reduces vascular complications and access related-bleeding compared to transfemoral approach (TFA). However, this technique has been related to higher radiation exposure during coronary angiography and percutaneous coronary intervention. Previous studies have shown that TRA demands a long learning curve, and procedure success rate increases with operator's experience. Our hypothesis is that the higher radiation exposure during TRA is not a technique issue, but due to operator's expertise. The aim of this study is to evaluate whether experienced operators with either TRA or TFA can perform diagnostic coronary angiography with similar radiation exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exposure to Ionizing Radiation, Coronary Heart Disease, Vascular Access Complication
Keywords
Occupational radiation exposure, Transradial approach, Transfemoral approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trans-radial access
Arm Type
Active Comparator
Arm Description
Coronary angiography performed through trans-radial access
Arm Title
Trans-femoral access
Arm Type
Active Comparator
Arm Description
Coronary angiography performed through trans-femoral access
Intervention Type
Other
Intervention Name(s)
Trans-radial
Intervention Description
Coronary angiography performed through trans-radial access
Intervention Type
Other
Intervention Name(s)
Trans-femoral
Intervention Description
Coronary angiography performed through trans-femoral access
Primary Outcome Measure Information:
Title
Patient radiation exposure (mGy)
Description
Patient radiation exposure (mGy)
Time Frame
during coronary angiography
Secondary Outcome Measure Information:
Title
Physician radiation exposure (in uSv)
Description
Physician radiation exposure (in uSv)
Time Frame
during coronary angiography
Other Pre-specified Outcome Measures:
Title
Major adverse cardiac events
Description
Major adverse cardiac events (death, stroke and vascular complications)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for a elective coronary angiography Eligible for either transfemoral or transradial approach Accept to sign the written consent form (WCF) Exclusion Criteria: Refusal to sign the WCF End stage renal failure Urgency/Emergency procedure Contraindication to perform both coronary and left ventricle angiogram Necessity of another vascular angiogram during coronary angiography
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiano O Cardoso, MD, MSc
Organizational Affiliation
Instituto de Cardiologia do Rio Grande do Sul
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luis M Yordi, MD
Organizational Affiliation
Hospital Ernesto Dornelles
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Claudio V Moraes, MD
Organizational Affiliation
Insituto de Cardiologia do Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Cardiologia do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90520-000
Country
Brazil

12. IPD Sharing Statement

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Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors

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