Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention

• Status: Completed
• Trial end date: 2019-05-02
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to determine the role of transdermal vasodilators as an adjunct to parenteral vasodilators in reducing radial artery spasm, improving patient comfort, and post procedure radial artery patency during transradial coronary angiograms and interventions. The study hypothesis is that transdermal vasodilators will increase radial artery size and reduce radial artery spasm as well as improve patient comfort and post procedure radial artery patency. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of transdermal preparations of lidocaine + nitroglycerine and lidocaine + placebo on radial artery spasm in patients undergoing transdermal coronary angiograms. Prior to the procedure, each patient will be randomized into either the control arm, lidocaine + placebo, or study arm, lidocaine + nitroglycerine.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aultman Health Foundation
• Treatments: Anesthetics; Anesthetics, Local; Lidocaine; Nitroglycerin

Criteria

Inclusion Criteria:

1. Age: 18 years or older

2. Radial artery catheterization

Exclusion Criteria:

1. Hypersensitivity or contraindication to lidocaine

2. Hypersensitivity or contraindication to nitroglycerine

3. Recent use of phosphodiesterase 5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)

4. Baseline weak radial pulse (0 or 1+)

5. Baseline hypotension SBP < 100 mmHg at the time of enrollment

6. Dizziness or light-headedness at the time of enrollment

7. Severe Aortic Stenosis or Hypertrophic obstructive cardiomyopathy

8. Previous unknown bypass grafts or known left internal mammary graft

9. Chest pain within 6 hours of IP administration

10. More than 2 episodes of chest pain within 24 hours prior to IP administration

11. Use of sublingual, transdermal, or intravenous nitroglycerine within 6 hours prior to IP administration

12. Likely need for use of nitroglycerine for non-study indication

13. Narcotic or sedative within 4 hours of enrollment

14. Women who are suspected or known to be pregnant or breastfeeding