Transradial and Transfemoral Coronary Angiography by EXPE... | NCT01794325

Studies
Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors

NCT01794325

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Status

Completed

Last Update Posted

Sep 17, 2014Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Exposure to Ionizing Radiation
Coronary Heart Disease
Vascular Access Complication

Interventions

Trans-radial
Trans-femoral

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Feb 15, 2013

First Submission Date that Met QC Criteria

Feb 15, 2013

First Posted Date

Feb 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2014

Last Update Posted Date

Sep 17, 2014Estimated

Name	Class
Hospital Ernesto Dornelles	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Trans-radial	Other	Coronary angiography performed through trans-radial access	Trans-radial access

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient radiation exposure (mGy)	Patient radiation exposure (mGy)	during coronary angiography

Secondary Outcomes

Measure	Description	Time Frame
Physician radiation exposure (in uSv)	Physician radiation exposure (in uSv)	during coronary angiography

Other Outcomes

Measure	Description	Time Frame
Major adverse cardiac events	Major adverse cardiac events (death, stroke and vascular complications)	30 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Cardiologia do Rio Grande do Sul		Porto Alegre	Rio Grande do Sul	90520-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided