Phase 1
N=19
Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00686231 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcome: Primary: Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin — -0.8; -0.2; 6.4; 2.5 percent diameter change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nitroglycerin 15mg (Drug); Nitroglycerin 30mg (Drug); Lidocaine 20mg (Drug); Lidocaine 40mg (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin |
-0.8; -0.2; 6.4; 2.5; 0.8; 14.9 | — |
| PRIMARY Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg) |
4; 4.9; 1.6; 3.4; 5.3; 11.0 | — |
Summary
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 in 2 visits to determine the effect of topical nitroglycerin on radial artery vasodilation. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours.
Eligibility Criteria
Inclusion Criteria
- Willing and able to give written informed consent and comply with study requirements
- Patient who speak English
Exclusion Criteria
- Presence or history of liver, cardiovascular, rheumatologic, cancer or renal disease.
- Current treatment with any vasodilator therapy
- Systolic blood pressure of less than 90 mmHg
- History of radial artery catheterization within the previous year
- Absence of radial artery blood flow in one or both arms
- Pregnancy.
- Active infection
- Staff members of the Cardiac Catheterization Laboratory.
Data sourced from ClinicalTrials.gov (NCT00686231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.