Left Versus Right Radial Artery and Radiation Exposure in Patients With Predictors of Trans-radial Failure
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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 |
- Dose area product [ Time Frame: During coronary angiography ] [ Designated as safety issue: Yes ]
- 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 2013 |
| Estimated Primary Completion Date: | August 2013 (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 |
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| Contact: John Coppola, MD | 2122635656 | John.Coppola@nyumc.org |
| Contact: Binita Shah, MD, MS | 917-864-3084 | binita.shah@nyumc.org |
| 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 | |
| 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: | October 15, 2012 |
| 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 May 16, 2013