Clinical trial NCT03622060: Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion
Official title: A Randomized Comparison of Post-procedural/Pre-hemostasis Intraarterial Nitroglycerin Versus Nicardipine to Reduce Radial Artery Occlusion After Transradial Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Radial Artery Injury at Wrist and Hand Level
Occlusion of Artery
Vasodilation
Lead sponsor: Hermina Heart Center Kemayoran
Sponsor class: OTHER
Collaborators: name: Hermina Hospital Group
First posted: 2018-08-09
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: nitroglycerin and nicardipine
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing transradial catheterization

Exclusion Criteria:

* Systolic blood pressure \< 100 mmHg

Primary outcomes:
measure: The absence of antegrade radial artery flow by doppler evaluation
timeFrame: 24 hour
measure: Blood pressure change
timeFrame: 2 minutes after drugs administration
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Hermina Heart Center
state: DKI Jakarta
Study officials:
affiliation: Hermina Hospital Kemayoran
name: Surya Dharma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 10.1002/ccd.25661. Epub 2014 Sep 13.