NCT03889470

Nitroglycerin as Spasmolytic Regimen for RAS Prevention in Radial Center

A Randomized Comparison of Nitroglycerin Versus Placebo as Spasmolytic Regimen to Prevent Moderate to Severe Radial Artery Spasm in Radial Center

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Hermina Heart Center Kemayoran · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The investigators will investigate whether administration of Nitroglycerin (NTG) as spasmolytic regimen reduces the incidence of moderate to severe radial artery spasm (RAS) in patients undergoing transradial catheterization in radial center.

Detailed description

Patients will be randomized to receive either 200 microgram NTG or placebo (saline) at the beginning of the procedure soon after radial sheath placement. The operators will be blinded to both assignment. The primary outcome is the incidence of moderate to severe RAS evaluated by the operators during the radial procedure. Both NTG and placebo will be administered using an identical syringe to keep the operators blinded to the treatment allocation. Radial angiogram is mandatory to measure the diameter of both radial and ulnar arteries. Doppler ultrasound of the radial artery will be examined at the day after the procedure.

Conditions

• Radial Artery Injury

Interventions

Type	Name	Description
DRUG	NTG 1 MG/ML Injectable Solution	administered after sheath placement

Timeline

• Start date: 2018-03-31
• Primary completion: 2019-09-30
• Completion: 2019-10-01
• First posted: 2019-03-26
• Last updated: 2019-06-04

Locations

1 site across 1 country: Indonesia