Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion

Vasodilation Clinical Trial

— NONERAO  

Official title:

A Randomized Comparison of Post-procedural/Pre-hemostasis Intraarterial Nitroglycerin Versus Nicardipine to Reduce Radial Artery Occlusion After Transradial Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622060
• Other study ID #: HerminaHCK
• Status: Completed
• Phase: Phase 3
• Start date: June 4, 2018
• Est. completion date: May 22, 2019

Study information

• Verified date: June 2019
• Source: Hermina Heart Center Kemayoran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 22, 2019
• Est. primary completion date: May 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

Inclusion Criteria:

• All patients undergoing transradial catheterization

Exclusion Criteria:

• Systolic blood pressure < 100 mmHg

Related Conditions & MeSH terms

• Occlusion of Artery
• Radial Artery Injury at Wrist and Hand Level
• Vasodilation

Intervention

Drug:
• Nitroglycerin
200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Hermina Heart Center Kemayoran	Hermina Hospital Group

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

Dharma S, Kedev S, Patel T, Kiemeneij F, Gilchrist IC. A novel approach to reduce radial artery occlusion after transradial catheterization: postprocedural/prehemostasis intra-arterial nitroglycerin. Catheter Cardiovasc Interv. 2015 Apr;85(5):818-25. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absence of antegrade radial artery flow by doppler evaluation	The absence of radial artery flow by doppler evaluation	24 hour
Primary	Blood pressure change	Blood pressure change after drugs administration	2 minutes after drugs administration