Trial Outcomes & Findings for Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter (NCT NCT00686231)

NCT ID: NCT00686231

Last Updated: 2020-03-06

Results Overview

Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 19 participants
• Primary outcome timeframe: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 1
• Results posted on: 2020-03-06

Participant Flow

Participant milestones

Measure	Dose-test 15mg 15mg Nitroglycerin on one wrist and Placebo on the other	Dose-test 30mg 30mg Nitroglycerin on one wrist and Placebo on the other	Combination Test 20mg 30mg Nitroglycerin + 20mg Lidocaine on one wrist, and Placebo + 20mg Lidocaine on the other wrist	Combination Test 40mg 30mg Nitroglycerin + 40mg Lidocaine on one wrist, and Placebo + 40mg Lidocaine on the other
Dose Test - Visit 1 STARTED	12	7	0	0
Dose Test - Visit 1 COMPLETED	12	7	0	0
Dose Test - Visit 1 NOT COMPLETED	0	0	0	0
Combination Test - Visit 2 STARTED	0	0	10	9
Combination Test - Visit 2 COMPLETED	0	0	10	9
Combination Test - Visit 2 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Overall Study n=19 Participants Healthy subjects older than 18 years were recruited and randomly assigned to one of two study arms on each of two separate study visits. Visit 1: 15mg Nitroglycerin vs. 30 mg Nitroglycerin on one wrist and placebo on the other wrist. Visit 2: 20mg Lidocaine vs. 40mg Lidocaine in combination with Nitroglycerin on one wrist and with placebo on the other wrist.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 1

Population: 19 participants were randomized to receive 15mg (n=12) or 30mg (n=7) nitroglycerin on one wrist, and placebo on the other

Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process.

Outcome measures

Measure	Placebo n=19 radial artery (wrist) Moisturizing skin cream as a matching placebo was topically applied to one wrist, where 15mg or 30mg (by random assignment) Nitroglycerin was applied to the other wrist	15mg Nitroglycerin n=12 radial artery (wrist) 15mg of nitroglycerin was administered topically on one wrist (where matching placebo was applied to the other wrist)	30mg Nitroglycerin n=7 radial artery (wrist) 30mg of nitroglycerin was administered topically on one wrist (where matching placebo was applied to the other wrist)	Lidocaine 40mg + Nitroglycerin 30mg 40mg combination test: lidocaine + nitroglycerin
Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin 60 minutes	3.3 percent diameter change Standard Deviation 6.5	10.2 percent diameter change Standard Deviation 5.4	21.5 percent diameter change Standard Deviation 6.6	—
Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin 120 minutes	5.9 percent diameter change Standard Deviation 6.5	8.8 percent diameter change Standard Deviation 10.1	28.5 percent diameter change Standard Deviation 12.1	—
Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin 10 minutes	-0.8 percent diameter change Standard Deviation 0.5	-0.2 percent diameter change Standard Deviation 2.8	6.4 percent diameter change Standard Deviation 4.5	—
Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin 30 minutes	2.5 percent diameter change Standard Deviation 12.5	0.8 percent diameter change Standard Deviation 3.5	14.9 percent diameter change Standard Deviation 18.1	—

PRIMARY outcome

Timeframe: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2

Population: 10 participants (20 wrists) received 30mg NTG + 20mg Lidocaine on one wrist, and placebo + 20mg Lidocaine on the other wrist; 9 participants (18 wrists) received 30mg NTG + 40mg Lidocaine on one wrist, and placebo + 40mg Lidocaine on the other wrist.

Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process. To compare combination of (Lidocaine + Nitroglycerin) or (Lidocaine + placebo), at visit 2, participants randomized to Comparison A received 30mg NTG + 20mg Lidocaine on one wrist, and placebo + 20mg Lidocaine on the other wrist; participants randomized to Comparison B received 30mg Nitroglycerin + 40mg Lidocaine on one wrist, and placebo + 40mg Lidocaine on the other wrist.

Outcome measures

Measure	Placebo n=10 Radial Artery Moisturizing skin cream as a matching placebo was topically applied to one wrist, where 15mg or 30mg (by random assignment) Nitroglycerin was applied to the other wrist	15mg Nitroglycerin n=10 Radial Artery 15mg of nitroglycerin was administered topically on one wrist (where matching placebo was applied to the other wrist)	30mg Nitroglycerin n=9 Radial Artery 30mg of nitroglycerin was administered topically on one wrist (where matching placebo was applied to the other wrist)	Lidocaine 40mg + Nitroglycerin 30mg n=9 Radial Artery 40mg combination test: lidocaine + nitroglycerin
Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg) 60 minutes	8.4 percent diameter change Standard Deviation 7.4	18.2 percent diameter change Standard Deviation 9.4	2.5 percent diameter change Standard Deviation 3.2	17.2 percent diameter change Standard Deviation 9.2
Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg) 10 minutes	4 percent diameter change Standard Deviation 3.6	4.9 percent diameter change Standard Deviation 7.2	1.6 percent diameter change Standard Deviation 3.0	3.4 percent diameter change Standard Deviation 3.0
Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg) 30 minutes	5.3 percent diameter change Standard Deviation 5.8	11.0 percent diameter change Standard Deviation 10.6	2.9 percent diameter change Standard Deviation 1.8	10.6 percent diameter change Standard Deviation 6.5
Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg) 120 minutes	5.7 percent diameter change Standard Deviation 6.8	18.5 percent diameter change Standard Deviation 8.7	4.1 percent diameter change Standard Deviation 3.9	22.1 percent diameter change Standard Deviation 12.0

Adverse Events

Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Boyle

UCSF

Phone: 415-514-0827

Email: aboyle@medicine.ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place