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CompletedNCT01794325EXPERTUpdated Sep 17, 2014

Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors

An interventional study of Trans-radial and Trans-femoral in Exposure to Ionizing Radiation, Coronary Heart Disease and Vascular Access Complication, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Completed at 1 site in Brazil. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-09-17.

Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Occupational radiation exposure
  • Transradial approach
  • Transfemoral approach
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 74 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Trans-radial access

    Coronary angiography performed through trans-radial access

    Other: Trans-radial

  • Active comparator
    Trans-femoral access

    Coronary angiography performed through trans-femoral access

    Other: Trans-femoral

Interventions

  • OtherTrans-radial

    Coronary angiography performed through trans-radial access

  • OtherTrans-femoral

    Coronary angiography performed through trans-femoral access

06

What researchers measure

Primary outcomes

  1. Patient radiation exposure (mGy)

    Patient radiation exposure (mGy)

    Time frame: during coronary angiography

Secondary outcomes

  1. Physician radiation exposure (in uSv)

    Physician radiation exposure (in uSv)

    Time frame: during coronary angiography

Other outcomes

  1. Major adverse cardiac events

    Major adverse cardiac events (death, stroke and vascular complications)

    Time frame: 30 days

07

Study locations

1 site
  • Instituto de Cardiologia do Rio Grande do Sul
    Porto Alegre, RS 90520-000, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01794325
Lead sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Hospital Ernesto Dornelles
Responsible party
Sponsor
First posted
Feb 18, 2013
Start date
Feb 2013
Primary completion
Jan 2014
Completion
Mar 2014
Last update
Sep 17, 2014

Study contacts

Cristiano O Cardoso, MD, MSc
study chair · Instituto de Cardiologia do Rio Grande do Sul
Luis M Yordi, MD
study director · Hospital Ernesto Dornelles
Claudio V Moraes, MD
principal investigator · Insituto de Cardiologia do Rio Grande do Sul

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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