Topical Radial Artery Vasodilation
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|ClinicalTrials.gov Identifier: NCT01155167|
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : May 15, 2013
Last Update Posted : May 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Catheterization Spasm||Drug: Nitroglycerin and lidocaine Other: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Topical Administration of Lidocaine/Nitroglycerin Combination Versus Placebo on Radial Artery Access in Patients Undergoing Cardiac Catheterization Via the Radial Artery|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2012|
|Placebo Comparator: Placebo||
|Experimental: Topical dilator||
Drug: Nitroglycerin and lidocaine
Topical Nitroglycerin and lidocaine
- Change in Radial Artery Diameter [ Time Frame: Baseline and after 30 minutes of drug application ]The cross-sectional radial artery area was measured using a high frequency linear array transducer. All ultrasound measurements were made 2 cm proximal to the radial styloid process. Each measurement was performed 3 times and averaged. At least 30 minutes after the application of topical creams, the radial artery diameter was again measured in the same fashion.
- Radial Artery Spasm During Catheterization [ Time Frame: 2 hours ]The blinded clinical operator recorded whether radial artery spasm occurred, as detected by resistance to advancing the catheter through the radial artery, by difficulty in torquing the catheter, or by difficulty in removing the catheter.
- Radial Artery Patency [ Time Frame: 24 hours ]Prior to discharge, color doppler ultrasound was used at the site where the sheath had been inserted to determine whether the radial artery was patent (open, unobstructed).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155167
|United States, California|
|University of California San Francisco Medical Center|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Andrew Boyle, MBBS, PhD||University of California, San Francisco|