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NCT01155167 Clinical Trial

Topical Radial Artery Vasodilation

Cardiac Catheterization Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01155167
Other study ID # 10035824
Secondary ID CHR # 10035824
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 2010
Est. completion date August 2012

Study information
Verified date May 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to facilitate radial artery access for cardiac catheterization. The investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized to topical nitroglycerin + lidocaine versus placebo.

Description:

The aim of the study is to facilitate radial artery access for cardiac catheterization. The investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized to topical nitroglycerin + lidocaine versus placebo.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date August 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Undergoing trans-radial cardiac catheterization

Exclusion Criteria:

- inability to receive nitroglycerin or lidocaine due to allergy or medication interactions

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nitroglycerin and lidocaine
Topical Nitroglycerin and lidocaine
Other:
• Placebo
Placebo

Locations
Country Name City State
United States University of California San Francisco Medical Center San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Radial Artery Diameter 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. Baseline and after 30 minutes of drug application
Secondary Radial Artery Spasm During Catheterization 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. 2 hours
Secondary Radial Artery Patency 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). 24 hours
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