Nitroglycerin Prevents Radial Artery Occlusion

Injury of Radial Artery Clinical Trial

— NORAO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105493
• Other study ID #: NORAO2014
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: April 2, 2014
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1706
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Injury of Radial Artery

Intervention

Drug:
• 500 microgram of Nitroglycerin
500 microgram of Nitroglycerin (in 5 mL saline) given intra-arterially through the sheath at the end of transradial procedure
• Saline 5 mL
Saline 5 mL given intra-arterially through the sheath at the end of transradial procedure

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center Harapan Kita	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound		One Day After the Index Procedure	No