Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 4:16 AM
Study NCT ID:
NCT03622060
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion
Sponsor:
Hermina Heart Center Kemayoran
Organization:
Study Overview
Official Title:
A Randomized Comparison of Post-procedural/Pre-hemostasis Intraarterial Nitroglycerin Versus Nicardipine to Reduce Radial Artery Occlusion After Transradial Catheterization
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NONERAO
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: