Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Nitroglycerin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing transradial catheterization Exclusion Criteria: Systolic blood pressure < 100 mmHg

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: nitroglycerin and nicardipine
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitroglycerin<br>500 microgram intraarterial Nitroglycerin | Drug: Nitroglycerin<br>* 200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal<br>* Other names: Nicardipine;|
| Placebo Comparator: Nicardipine<br>200 microgram intraraterial Nicardipine | Drug: Nitroglycerin<br>* 200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal<br>* Other names: Nicardipine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of antegrade radial artery flow by doppler evaluation | The absence of radial artery flow by doppler evaluation | 24 hour | 
| Blood pressure change | Blood pressure change after drugs administration | 2 minutes after drugs administration |