Phase 4
Completed N=100
Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention
Radial Artery Spasm · Angina · Coronary Artery Disease
Source: ClinicalTrials.gov NCT02832115 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Radial Artery Spasm — 8; 15 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radial Artery Spasm |
8; 15 | — |
| SECONDARY Change in Radial Artery Dimension Measured in mm^2. |
2.5; -0.2 | — |
| SECONDARY Number of Patients With Procedural Failure |
0; 4 | — |
| SECONDARY Patient Discomfort or Pain During Procedure (Visual Analog Scale 0-10) |
0.792; 0.875 | — |
| SECONDARY Radial Pulse at End of Procedure |
2.208333333; 2.166666667 | — |
Eligibility Criteria
Inclusion Criteria
- Age: 18 years or older
- Radial artery catheterization
Exclusion Criteria
- Hypersensitivity or contraindication to lidocaine
- Hypersensitivity or contraindication to nitroglycerine
- Recent use of phosphodiesterase 5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)
- Baseline weak radial pulse (0 or 1+)
- Baseline hypotension SBP < 100 mmHg at the time of enrollment
- Dizziness or light-headedness at the time of enrollment
- Severe Aortic Stenosis or Hypertrophic obstructive cardiomyopathy
- Previous unknown bypass grafts or known left internal mammary graft
- Chest pain within 6 hours of IP administration
- More than 2 episodes of chest pain within 24 hours prior to IP administration
- Use of sublingual, transdermal, or intravenous nitroglycerine within 6 hours prior to IP administration
- Likely need for use of nitroglycerine for non-study indication
- Narcotic or sedative within 4 hours of enrollment
- Women who are suspected or known to be pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT02832115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.