NCT03158532

Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,040 (actual)
• Sponsor: Instituto de Cardiologia de Santa Catarina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The radial approach for a coronary angiography has became popular in several centers because of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. Several strategies have been used to decrease the incidence of RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the start of catheterization would have the same effect was not tested.

Detailed description

Transradial access (TRA) has been increasingly adopted for diagnostic and interventional cardiovascular procedures in many centers worldwide. This is largely driven by the evidence supporting an unequivocal reduction in access site-related complications associated with TRA compared with transfemoral access, as well as reduction in cost and increased patient comfort. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. RAO is the most commun complication of transradial access, and its incidence continues to reach up to 12%. Nitrates in intra-arterial have been widely studied in prevention of this spasm. Nitroglycerin binds to the surface of endothelial cells and undergoes two chemical reductions to form nitric oxide (NO). The nitric oxide then moves out of the endothelial cell and into an adjacent smooth muscle cell, where it promotes the formation of cyclic guanosine monophosphate (cGMP), which then promotes muscle relaxation. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of radial artery occlusion. A big sheath to artery size ratio could reduce the incidence of RAO, so the main objective of this study is to evaluate whether administration of nitroglycerin at the start of a transradial procedure may preserve the patency of the radial artery; as well, confirm if nitroglycerin administration just before sheet removal helps to keep the radial artery patency.

Conditions

• Injury of Radial Artery

Interventions

Type	Name	Description
DRUG	Nitroglycerin I	500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
DRUG	Placebo I	Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
DRUG	Nitroglycerin II	500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
DRUG	Placebo II	Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

Timeline

• Start date: 2017-07-06
• Primary completion: 2021-10-01
• Completion: 2021-11-01
• First posted: 2017-05-18
• Last updated: 2024-12-09
• Results posted: 2024-12-09

Locations

3 sites across 1 country: Brazil