Nitroglycerin as Spasmolytic Regimen for RAS Prevention in Radial Center

Phase 4

• Conditions: Radial Artery Injury
• Interventions: Drug: NTG 1 MG/ML Injectable Solution

• Registration Number: NCT03889470
• Lead Sponsor: Hermina Heart Center Kemayoran

Brief 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.

Study Timeline

• Study Start: 2018-03-31
• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-01
• Last Update Posted: 2019-06-04
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• Blood pressure <100 mmHg
• Refuse to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	NTG 1 MG/ML Injectable Solution	Saline infusion through the radial sheath
200 microgram NTG	NTG 1 MG/ML Injectable Solution	200 microgram NTG through the radial sheath

Primary Outcome Measures

Name	Time	Method
The incidence of Moderate to severe radial artery spasm	During the index procedure	arm pain associated with catheter manipulation (RAS grade 2 to 4)

Trial Locations

Locations (1)

Hermina Heart Center; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia