Nitroglycerin Prevents Radial Artery Occlusion

Not Applicable

Completed

• Conditions: Injury of Radial Artery
• Interventions: Drug: Saline 5 mL; Drug: 500 microgram of Nitroglycerin

• Registration Number: NCT02105493
• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-02
• Study First Submitted: 2014-02-19
• Status Verified: 2014-03
• Study Completion: 2014-03
• Study First Submitted QC: 2014-04-02
• Last Update Submitted: 2014-04-02
• Study First Posted: 2014-04-07
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1706

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline 5 mL	Saline 5 mL	0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure
500 microgram of Nitroglycerin	500 microgram of Nitroglycerin	500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure

Primary Outcome Measures

Name	Time	Method
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound	One Day After the Index Procedure

Trial Locations

Locations (1)

National Cardiovascular Center Harapan Kita; 🇮🇩 Jakarta, Indonesia