Nitroglycerin as Spasmolytic Regimen for RAS Prevention in Radial Center (NORAS)

Hermina Heart Center Kemayoran

Status and phase: Unknown; Phase 4

Conditions: Radial Artery Injury

Treatments: Drug: NTG 1 MG/ML Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03889470

HerminaHCKRAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Blood pressure <100 mmHg
• Refuse to participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups, including a placebo group

200 microgram NTG

Active Comparator group

Description:

200 microgram NTG through the radial sheath

Treatment:

Drug: NTG 1 MG/ML Injectable Solution

Saline

Placebo Comparator group

Description:

Saline infusion through the radial sheath

Treatment:

Drug: NTG 1 MG/ML Injectable Solution