Nitroglycerin Prevents Radial Artery Occlusion (NORAO)

National Cardiovascular Center Harapan Kita Hospital Indonesia

Status: Completed

Conditions: Injury of Radial Artery

Treatments: Drug: 500 microgram of Nitroglycerin; Drug: Saline 5 mL

Study type: Interventional

Funder types: Other

Identifiers

NCT02105493

NORAO2014

Details and patient eligibility

About

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.

Enrollment: 1,706 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,706 participants in 2 patient groups, including a placebo group

500 microgram of Nitroglycerin

Active Comparator group

Description:

500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure

Treatment:

Drug: 500 microgram of Nitroglycerin

Saline 5 mL

Placebo Comparator group

Description:

0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure

Treatment:

Drug: Saline 5 mL