Topical Radial Artery Vasodilation

Phase 2

Completed

• Conditions: Cardiac Catheterization; Spasm
• Interventions: Other: Placebo; Drug: Nitroglycerin and lidocaine

• Registration Number: NCT01155167
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-30
• Study Start: 2010-07
• Study First Posted: 2010-07-01
• Primary Completion: 2011-08
• Study Completion: 2012-08
• Results First Submitted: 2013-01-31
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-13
• Results First Posted: 2013-05-15
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Undergoing trans-radial cardiac catheterization

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Topical dilator	Nitroglycerin and lidocaine	-

Primary Outcome Measures

Name	Time	Method
Change in Radial Artery Diameter	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.

Secondary Outcome Measures

Name	Time	Method
Radial Artery Spasm During Catheterization	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	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).

Trial Locations

Locations (1)

University of California San Francisco Medical Center; 🇺🇸 San Francisco, California, United States