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Topical Radial Artery Vasodilation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01155167
First received: June 29, 2010
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Cardiac Catheterization
Spasm
 Drug: Nitroglycerin and lidocaine
Other: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in Radial Artery Diameter [ Time Frame: Baseline and after 30 minutes of drug application ] [ Designated as safety issue: No ]
    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:
  • Radial Artery Spasm During Catheterization [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The blinded clinical operator recorded the presence and grade of radial artery spasm, 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 ] [ Designated as safety issue: Yes ]
    Prior to discharge, radial artery patency was documented by color doppler ultrasound at the site where the sheath had been inserted.


Enrollment: 86
Study Start Date: July 2010
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Placebo
Experimental: Topical dilator Drug: Nitroglycerin and lidocaine
Topical Nitroglycerin and lidocaine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155167

Locations
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
Principal Investigator: Andrew Boyle, MBBS, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01155167     History of Changes
Other Study ID Numbers: NCT0061169, CHR # 10035824
Study First Received: June 29, 2010
Results First Received: January 31, 2013
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
radial artery spasm

Additional relevant MeSH terms:
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nitroglycerin
Lidocaine
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on May 21, 2013