Nitroglycerin Prevents Radial Artery Occlusion

Study Overview
=================
Brief Summary
-----------------
Trans-radial approach (TRA) has becoming popular and widely adopted over the last decade. However, radial artery occlusion (RAO) continues to be one of the limitation of trans-radial access and potentially limits the radial artery as an access site in the future. Several strategies have been used to decrease the incidence of RAO including the use of anticoagulation, maintenance of patency during hemostasis, or shortening the duration of compression. Currently, there is no data whether vasoactive pharmacological therapy such as nitroglycerin administered intra-arterially at the end of the procedure may reduce the incidence of RAO. It is hypothesized that the addition of nitroglycerin (nitric oxide donor) at the end of a TRA procedure may reduce the incidence of RAO.

Official Title
-----------------
A Novel Approach to Reduce Radial Artery Occlusion After Trans-Radial Catheterization: Post-Procedural/Pre-Hemostasis Intra-Arterial Nitroglycerin

Conditions
-----------------
Injury of Radial Artery

Intervention / Treatment
-----------------
* Drug: 500 microgram of Nitroglycerin
* Drug: Saline 5 mL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sequential patients undergoing trans-radial catheterization in the institution will be consented to be randomized to receive either 500 microgram nitroglycerin (Group A) or a placebo (Group B) administered intra-arterially through the sheath at the end of the procedure. Exclusion Criteria: Patients with cardiogenic shock or hemodynamically unstable Unable to tolerate nitrates

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 500 microgram of Nitroglycerin<br>500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure | Drug: 500 microgram of Nitroglycerin<br>* 500 microgram of Nitroglycerin (in 5 mL saline) given intra-arterially through the sheath at the end of transradial procedure<br>* Other names: NTG;|
| Placebo Comparator: Saline 5 mL<br>0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure | Drug: Saline 5 mL<br>* Saline 5 mL given intra-arterially through the sheath at the end of transradial procedure<br>* Other names: NaCl 0,9% 5mL;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound |  | One Day After the Index Procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nitroglycerin, Radial Artery Occlusion, Transradial Catheterization