Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion (NONERAO)

Hermina Heart Center Kemayoran

Status and phase: Completed; Phase 3

Conditions: Vasodilation; Radial Artery Injury at Wrist and Hand Level; Occlusion of Artery

Treatments: Drug: Nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT03622060

HerminaHCK

Details and patient eligibility

About

A total of 600 patients undergoing coronary procedures via transradial access using 6F sheath were randomized at the end of the procedure to receive either 250-µg nicardipine or 500-µg nitroglycerin administered to the radial artery through the radial sheath before sheath removal. A continuous patent hemostasis was applied in each patient with the use of an oximetry to maintain an oxygen saturation of >95%, measured in the finger of the accessed arm until compression device was totally removed. The primary outcome is early RAO which was evaluated by color duplex ultrasonography of the accessed arteries at the day after the radial procedure. Secondary outcome was the change of blood pressure at 2-3 minutes after drug administration. Radial artery angiogram was performed after radial sheath insertion and doppler ultrasound of the accesed radial artery was examined at the day after the procedure.

Full description

Doppler ultrasound of the accessed artery was performed at the day after the radial procedure in all patients. The absence or presence of antegrade flow in the radial artery will be examined while compressing the ulnar artery as previously described.

The internal lumen radial artery diameter was evaluated by doppler ultrasound as the distance between the inner walls of the artery by personnel that are blinded to the study protocol.

Radial artery angiogram was performed soon after radial sheath insertion and the radial artery diameter was measured in AP projection in all patients.

Enrollment: 600 patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing transradial catheterization

Exclusion criteria

• Systolic blood pressure < 100 mmHg

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups, including a placebo group

Nitroglycerin

Active Comparator group

Description:

500 microgram intraarterial Nitroglycerin

Treatment:

Drug: Nitroglycerin

Nicardipine

Placebo Comparator group

Description:

200 microgram intraraterial Nicardipine

Treatment:

Drug: Nitroglycerin