CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Topical Nitroglycerine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02832115
NCT02832115Phase 4Completed

Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention

Aultman Health Foundation·interventional·Posted Jul 14, 2016·Updated Oct 27, 2020

In Brief

A Phase 4 clinical trial evaluating Topical Nitroglycerine and Topical Lidocaine for Radial Artery Spasm and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 14, 2016
Enrollment StartSep 1, 2016
Primary CompletionMay 2, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.0 years ago

Interventions

Topical Nitroglycerinedrug

Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients

Topical Lidocainedrug

Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms