Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention
Condition: Radial Artery Spasm; Angina; Coronary Artery Disease
MeSH terms: Spasm; Coronary Artery Disease; Peripheral Vascular Diseases
Intervention: Topical Nitroglycerine; Topical Lidocaine
Intervention description: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients; Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms
Intervention MeSH terms: Lidocaine; Nitroglycerin; Anesthetics, Local; Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac Catheterization; Vascular Access Site Complications; Vasodilator; Nitroglycerine; Lidocaine

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.
    

Eligibility 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