Nitroglycerin as Spasmolytic Regimen for RAS Prevention in Radial Center

Radial Artery Injury Clinical Trial

— NORAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03889470
• Other study ID #: HerminaHCKRAS
• Status: Recruiting
• Phase: Phase 4
• Start date: March 31, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: June 2019
• Source: Hermina Heart Center Kemayoran
• Contact: Agnes Intan, MD
• Phone: 622122608047
• Email: agnesintan1231[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 1, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients undergoing transradial catheterisation using proximal radial artery puncture technique

Exclusion Criteria:

• Blood pressure <100 mmHg

• Refuse to participate

Related Conditions & MeSH terms

• Radial Artery Injury

Intervention

Drug:
• NTG 1 MG/ML Injectable Solution
administered after sheath placement

Locations

Country	Name	City	State
Indonesia	Hermina Heart Center	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Hermina Heart Center Kemayoran

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of Moderate to severe radial artery spasm	arm pain associated with catheter manipulation (RAS grade 2 to 4)	During the index procedure