NCT01794325

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

February 15, 2013

Last Update Submit

September 16, 2014

Conditions

Exposure to Ionizing RadiationCoronary Heart DiseaseVascular Access Complication

Keywords

Occupational radiation exposureTransradial approachTransfemoral approach

Outcome Measures

Primary Outcomes (1)

  • Patient radiation exposure (mGy)

    Patient radiation exposure (mGy)

    during coronary angiography

Secondary Outcomes (1)

  • Physician radiation exposure (in uSv)

    during coronary angiography

Other Outcomes (1)

  • Major adverse cardiac events

    30 days

Study Arms (2)

Trans-radial access

ACTIVE COMPARATOR

Coronary angiography performed through trans-radial access

Other: Trans-radial

Trans-femoral access

ACTIVE COMPARATOR

Coronary angiography performed through trans-femoral access

Other: Trans-femoral

Interventions

Trans-radialOTHER

Coronary angiography performed through trans-radial access

Trans-radial access
Trans-femoralOTHER

Coronary angiography performed through trans-femoral access

Trans-femoral access

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

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, 90520-000, Brazil

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Cristiano O Cardoso, MD, MSc

    Instituto de Cardiologia do Rio Grande do Sul

    STUDY CHAIR

  • Luis M Yordi, MD

    Hospital Ernesto Dornelles

    STUDY DIRECTOR

  • Claudio V Moraes, MD

    Insituto de Cardiologia do Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 18, 2013

Study Start

February 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

BR(1)