Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion

Phase 3

Completed

• Conditions: Radial Artery Injury at Wrist and Hand Level; Occlusion of Artery; Vasodilation
• Interventions: Drug: Nitroglycerin

• Registration Number: NCT03622060
• Lead Sponsor: Hermina Heart Center Kemayoran

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-06-04
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-04
• Study First Posted: 2018-08-09
• Primary Completion: 2019-05-21
• Study Completion: 2019-05-22
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-01
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• All patients undergoing transradial catheterization

Exclusion Criteria

• Systolic blood pressure < 100 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitroglycerin	Nitroglycerin	500 microgram intraarterial Nitroglycerin
Nicardipine	Nitroglycerin	200 microgram intraraterial Nicardipine

Primary Outcome Measures

Name	Time	Method
The absence of antegrade radial artery flow by doppler evaluation	24 hour	The absence of radial artery flow by doppler evaluation
Blood pressure change	2 minutes after drugs administration	Blood pressure change after drugs administration

Trial Locations

Locations (1)

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