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Topical Radial Artery Vasodilation

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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cardiac Catheterization
Spasm
Interventions Drug: Nitroglycerin and lidocaine
Other: Placebo
Enrollment 86
Recruitment Details Eligible patients scheduled to undergo clinically indicated diagnostic or therapeutic cardiac catheterization via the transradial approach were invited to participate in the study
Pre-assignment Details 3 participants from the placebo group were excluded (2 secondary to insufficient or uninterpretable ultrasound data and 1 secondary to patient's access site change from transradial access (TRA) to femoral access).
Arm/Group Title Placebo Topical Dilator
Hide Arm/Group Description Two placebo topical lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time. 40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
Period Title: Overall Study
Started 43 43
Completed 40 43
Not Completed 3 0
Reason Not Completed
Insufficient ultrasound data             2             0
Access site changed to femoral artery             1             0
Arm/Group Title Placebo Topical Dilator Total
Hide Arm/Group Description Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time. 40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time. Total of all reporting groups
Overall Number of Baseline Participants 40 43 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 83 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  52.5%
22
  51.2%
43
  51.8%
>=65 years
19
  47.5%
21
  48.8%
40
  48.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 43 participants 83 participants
59  (12.8) 63.4  (12.6) 61.2  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 83 participants
Female
14
  35.0%
14
  32.6%
28
  33.7%
Male
26
  65.0%
29
  67.4%
55
  66.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 43 participants 83 participants
40 43 83
1.Primary Outcome
Title Change in Radial Artery Diameter
Hide Description 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.
Time Frame Baseline and after 30 minutes of drug application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Topical Dilator
Hide Arm/Group Description:
Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
Overall Number of Participants Analyzed 40 43
Mean (Standard Deviation)
Unit of Measure: Percent change
-5.6  (2.1) 16.5  (4.2)
2.Secondary Outcome
Title Radial Artery Spasm During Catheterization
Hide Description 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.
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants except 3 participants in the Topical Dilator arm for whom RAS data were not recorded
Arm/Group Title Placebo Topical Dilator
Hide Arm/Group Description:
Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
Spasm 10 10
No spasm 30 30
3.Secondary Outcome
Title Radial Artery Patency
Hide Description 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).
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Placebo Topical Dilator
Hide Arm/Group Description:
Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
Overall Number of Participants Analyzed 40 43
Measure Type: Number
Unit of Measure: participants
Patent radial artery 39 43
Early radial artery occlusion 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Topical Dilator
Hide Arm/Group Description Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time. 40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
All-Cause Mortality
Placebo Topical Dilator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Topical Dilator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Topical Dilator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/43 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Andrew Boyle MD
Organization: UCSF
Phone: 4153533817
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01155167     History of Changes
Other Study ID Numbers: 10035824
CHR # 10035824 ( Other Identifier: UCSF )
First Submitted: June 29, 2010
First Posted: July 1, 2010
Results First Submitted: January 31, 2013
Results First Posted: May 15, 2013
Last Update Posted: September 25, 2018