COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topical Radial Artery Vasodilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01155167
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : May 15, 2013
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cardiac Catheterization Spasm Drug: Nitroglycerin and lidocaine Other: Placebo Phase 2 Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
Placebo
Experimental: Topical dilator Drug: Nitroglycerin and lidocaine
Topical Nitroglycerin and lidocaine


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing trans-radial cardiac catheterization

Exclusion Criteria:

  • inability to receive nitroglycerin or lidocaine due to allergy or medication interactions
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Andrew Boyle, MBBS, PhD University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01155167    
Other Study ID Numbers: 10035824
CHR # 10035824 ( Other Identifier: UCSF )
First Posted: July 1, 2010    Key Record Dates
Results First Posted: May 15, 2013
Last Update Posted: September 25, 2018
Last Verified: May 2013
Keywords provided by University of California, San Francisco:
radial artery spasm
Additional relevant MeSH terms:
Layout table for MeSH terms
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Lidocaine
Nitroglycerin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents