Nitroglycerin Prevents Radial Artery Occlusion

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.

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Key information

Conditions

Injury of Radial Artery Arterial Occlusive Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cardiovascular Center Harapan Kita

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

500 microgram of Nitroglycerin

Drug

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

Other names: NTG

Saline 5 mL

Drug

Saline 5 mL given intra-arterially through the sheath at the end of transradial procedure

Other names: NaCl 0,9% 5mL

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

Sponsors and collaborators

Lead sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Other

Registry information

Official study title

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

Acronym: NORAO

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Apr 7, 2014
Registry last updated: Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed