NCT02343276

Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Instituto de Cardiologia de Santa Catarina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second group will receive saline 0.9% in the same volume and time during the procedure (control group). Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.

Conditions

• Cardiac Catheterisation

Interventions

Type	Name	Description
DRUG	Nitroglycerin	Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion
OTHER	Placebo	Placebo (saline solution 10 ml) in radial artery after sheath insertion

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-01-21
• Last updated: 2019-05-31
• Results posted: 2019-05-31

Locations

1 site across 1 country: Brazil