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
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: Randomized left versus right radial artery approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Left Versus Right Radial Artery Access on Radiation Exposure in Patients With Predictors of Potential Trans-radial Access Failure

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Dose area product [ Time Frame: During coronary angiography ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trans-radial approach
Randomized left versus right radial artery approach
Procedure: Randomized left versus right radial artery approach
Randomized left versus right radial artery approach
No Intervention: Trans-femoral approach
Observational

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707524

Contacts
Contact: John Coppola, MD 2122635656 John.Coppola@nyumc.org
Contact: Binita Shah, MD, MS 917-864-3084 binita.shah@nyumc.org

Locations
United States, New York
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: John Coppola, MD    212-263-5656    john.coppola@nyumc.org   
Contact: Binita Shah, MD, MS    917-864-3084    binita.shah@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: John Coppola, MD New York University School of Medicine
Principal Investigator: Binita Shah, MD, MS New York University School of Medicine
  More Information

No publications provided

Responsible Party: John Coppola, Assistant Professor of Medicine, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01707524     History of Changes
Other Study ID Numbers: S12-02885
Study First Received: October 12, 2012
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014