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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 : May 27, 2013
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Placebo 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.
Topical Dilator 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.

Participant Flow:   Overall Study
    Placebo   Topical Dilator
STARTED   43   43 
COMPLETED   40   43 
NOT COMPLETED   3   0 
Insufficient ultrasound data                2                0 
Access site changed to femoral artery                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 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.
Topical Dilator 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 Total of all reporting groups

Baseline Measures
   Placebo   Topical Dilator   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   43   83 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   21   22   43 
>=65 years   19   21   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 59  (12.8)   63.4  (12.6)   61.2  (12.7) 
Gender 
[Units: Participants]
     
Female   14   14   28 
Male   26   29   55 
Region of Enrollment 
[Units: Participants]
     
United States   40   43   83 


  Outcome Measures

1.  Primary:   Change in Radial Artery Diameter   [ Time Frame: Baseline and after 30 minutes of drug application ]

2.  Secondary:   Radial Artery Spasm During Catheterization   [ Time Frame: 2 hours ]

3.  Secondary:   Radial Artery Patency   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: aboyle@medicne.ucsf.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01155167     History of Changes
Other Study ID Numbers: NCT0061169
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: May 27, 2013