Left Versus Right Radial Artery and Radiation Exposure in Patients With Predictors of Trans-radial Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
John Coppola, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01707524
First received: October 12, 2012
Last updated: February 19, 2014
Last verified: February 2014

October 12, 2012
February 19, 2014
August 2012
August 2014   (final data collection date for primary outcome measure)
Dose area product [ Time Frame: During coronary angiography ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01707524 on ClinicalTrials.gov Archive Site
  • total fluoroscopy time [ Time Frame: during coronary angiography and PCI ] [ Designated as safety issue: Yes ]
  • total radiation dose [ Time Frame: during coronary angiography and PCI ] [ Designated as safety issue: Yes ]
  • number of catheters used [ Time Frame: during coronary angiography ] [ Designated as safety issue: No ]
  • incidence of subclavian tortuosity [ Time Frame: during coronary angiography ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Left Versus Right Radial Artery and Radiation Exposure in Patients With Predictors of Trans-radial Failure
Effect of Left Versus Right Radial Artery Access on Radiation Exposure in Patients With Predictors of Potential Trans-radial Access Failure

The aim of this study is to measure radiation exposure during coronary angiography (CA) with a trans-radial approach (TRA), specifically comparing access via the left versus right radial artery in patients with suggested clinical predictors of TRA failure/difficult. These predictors include age >70, female gender, height <64 inches, and history of hypertension.The study also aims to determine difficulties encountered during left or right radial access in this specific patient population. A secondary aim is to compare the results of enrolled patients with a registry of patients where femoral access was obtained.

Currently more than 1 million percutaneous coronary interventions (PCI) are performed in the United States annually. There is a growing trend to perform procedures utilizing the TRA due to recent data demonstrating decreased bleeding and access-site complications compared to the femoral approach. However, the TRA approach is also know to be associated with greater radiation exposure compared to the femoral approach. Furthermore, the TRA to catheterization may be difficult in certain populations because of anatomic considerations. Though traditionally completed via canalization of the right radial artery (RRA) due to feasibility with room setup, left radial artery (LRA) access may be superior due to the shorter distance needed to reach the ascending aorta and bypassing the tortuosity of the right subclavian artery. Given the benefits of the TRA, it is important to determine how left versus right radial artery access affects parameters of radiation exposure in addition to procedural difficulty.

This study will be a prospective, randomized study of patients with suggested predictors of TRA failure/difficulty referred for coronary angiography. Patients referred for coronary angiography using the trans-radial approach will be randomly assigned to obtain arterial access via the right or left radial artery. A registry of patients referred for coronary angiography using the trans-femoral approach will be compiled. The primary outcome measure will be radiation exposure as measured by dose area product output from the coronary angiography system. Secondary measures will include the total fluoroscopy time, total dose of radiation, number of catheters used, and incidence of subclavian tortuosity. In addition, procedural complications and success rates will also be evaluated.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Procedure: Randomized left versus right radial artery approach
Randomized left versus right radial artery approach
  • Experimental: Trans-radial approach
    Randomized left versus right radial artery approach
    Intervention: Procedure: Randomized left versus right radial artery approach
  • No Intervention: Trans-femoral approach
    Observational
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients referred for cardiac catheterization procedure with 3 out of the following 4 characteristics: age ≥70 years, female gender, hypertensive, and ≤64 inches in height.

Exclusion Criteria:

Patients will be excluded if they 1) underwent prior CABG with utilization of an internal mammary artery, 2) have an abnormal Allen test, 3) require emergency cardiac catheterization, 4) are planned to undergo a staged PCI procedure, 5) do not consent or are unable to give consent, or 6) are participating in another competing study.

Both
18 Years and older
No
Contact: John Coppola, MD 2122635656 John.Coppola@nyumc.org
Contact: Binita Shah, MD, MS 917-864-3084 binita.shah@nyumc.org
United States
 
NCT01707524
S12-02885
Not Provided
John Coppola, New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: John Coppola, MD New York University School of Medicine
Principal Investigator: Binita Shah, MD, MS New York University School of Medicine
New York University School of Medicine
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP