A Novel Approach to Reduce Radial Artery Occlusion After Trans-Radial Catheterization: Post-Procedural/Pre-Hemostasis Intra-Arterial Nitroglycerin
Overview
- Phase
- Not Applicable
- Intervention
- 500 microgram of Nitroglycerin
- Conditions
- Injury of Radial Artery
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Enrollment
- 1706
- Locations
- 1
- Primary Endpoint
- Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound
- Status
- Completed
- Last Updated
- 12 years ago
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.
Investigators
Surya Dharma, MD, PhD
MD, PhD
National Cardiovascular Center Harapan Kita Hospital Indonesia
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
Arms & Interventions
500 microgram of Nitroglycerin
500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure
Intervention: 500 microgram of Nitroglycerin
Saline 5 mL
0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure
Intervention: Saline 5 mL
Outcomes
Primary Outcomes
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound
Time Frame: One Day After the Index Procedure