Phase 1 Completed N=19 Randomized Single-blind Other

Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter

Healthy

Source: ClinicalTrials.gov NCT00686231 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2010

Primary outcomePrimary: Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin — -0.8; -0.2; 6.4; 2.5 percent diameter change

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.

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	—

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.

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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. Informational only — not medical advice.