Topical Radial Artery Vasodilation
The Effect of Topical Administration of Lidocaine/Nitroglycerin Combination Versus Placebo on Radial Artery Access in Patients Undergoing Cardiac Catheterization Via the Radial Artery
2 other identifiers
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
July 1, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
May 15, 2013
CompletedSeptember 25, 2018
May 1, 2013
1.1 years
June 29, 2010
January 31, 2013
September 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Radial Artery Spasm During Catheterization
2 hours
Radial Artery Patency
24 hours
Study Arms (2)
Placebo
PLACEBO COMPARATORTopical dilator
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Undergoing trans-radial cardiac catheterization
You may not qualify if:
- inability to receive nitroglycerin or lidocaine due to allergy or medication interactions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Related Publications (1)
Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, Ports TA, Boyle AJ. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol. 2013 Oct 3;168(3):2575-8. doi: 10.1016/j.ijcard.2013.03.048. Epub 2013 Apr 10.
PMID: 23582415DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Boyle MD
- Organization
- UCSF
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Boyle, MBBS, PhD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2010
First Posted
July 1, 2010
Study Start
July 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2012
Last Updated
September 25, 2018
Results First Posted
May 15, 2013
Record last verified: 2013-05