Clinical trial NCT01707524: Left Versus Right Radial Artery and Radiation Exposure in Patients With Predictors of Trans-radial Failure
Official title: Effect of Left Versus Right Radial Artery Access on Radiation Exposure in Patients With Predictors of Potential Trans-radial Access Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Dose area product
timeFrame: During coronary angiography
Secondary outcomes:
measure: total fluoroscopy time
timeFrame: during coronary angiography and PCI
measure: total radiation dose
timeFrame: during coronary angiography and PCI
measure: number of catheters used
timeFrame: during coronary angiography
measure: incidence of subclavian tortuosity
timeFrame: during coronary angiography
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: John Coppola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Binita Shah, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: