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Sponsored by: |
University of California, San Francisco |
Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00686231 |
The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood supply. In order to facilitate successful catheterization of the artery, a dilated artery and one free of arterial spasm is desirable. The proposed study will randomize twenty three healthy subjects to determine the effect of topical nitroglycerin on radial artery vasodilation. In the first phase of the study, which is a dose escalation study, each subject will receive either one or two inches of nitroglycerin in a blinded manner on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. The subjects will then return at a later date at which point they will receive the alternate dose on one wrist and placebo on the other. In the second phase of the study, we will randomize the same patients to a mixture of topical nitroglycerin and lidocaine or topical lidocaine alone. Measurements of radial artery diameter will be performed as in the first study.
Condition | Intervention | Phase |
Healthy |
Drug: Nitroglycerin Drug: Placebo Drug: Lidocaine |
Phase I |
MedlinePlus related topics: | Anesthesia |
ChemIDplus related topics: | Nitroglycerin Lidocaine Sorbolene |
Study Type: | Interventional |
Study Design: | Other, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter |
Estimated Enrollment: | 20 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Placebo: Placebo Comparator
Sorbolene cream
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Drug: Placebo
Sorbolene cream
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Lidocaine: Experimental
Lidocaine 1 inch
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Drug: Lidocaine
Visit 2 lidocaine 1 inch + best dose Nitro vs Placebo + lidocaine
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Nitro: Experimental
1 inch / 2 inches of Nitroglycerin applied topically to the wrist
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Drug: Nitroglycerin
1 inch of Nitroglycerin vs 2 inches of Nitroglycerin
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
UCSF Medical Center | Recruiting | ||||
San Francisco, California, United States, 94143 | |||||
Contact: Andrew Boyle, MBBS 415-502-1310 aboyle@medicine.ucsf.edu | |||||
Principal Investigator: Andrew Boyle, MBBS | |||||
Sub-Investigator: Yerem Yeghiazarians, MD |
University of California, San Francisco |
Responsible Party: | UCSF ( Dr. Andrew Boyle ) |
Study ID Numbers: | 56438-31921 |
First Received: | May 19, 2008 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00686231 |
Health Authority: | United States: Institutional Review Board |
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