A Phase 1 interventional study of Nitroglycerin 15mg and Nitroglycerin 30mg in Healthy, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-06.
Sponsored by University of California, San Francisco · Phase 1, Interventional, and Other
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.
During the first study visit, as a dose-optimizing study, each subject will be randomly assigned to one of two Dose-Test arms to receive either 15mg or 30mg of nitroglycerin on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. On the second study visit, the same participants will be randomly assigned to one of two Combination-Test arms to receive bilateral topical application of either 20mg or 40mg of lidocaine; the lidocaine will be applied in combination with 30mg of nitroglycerin on one wrist and in combination with placebo on the other wrist. Measurements of radial artery diameter will be performed as in the first visit.
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1
Drug: Nitroglycerin 15mg · Drug: Placebo
Nitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1
Drug: Nitroglycerin 30mg · Drug: Placebo
Lidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the other wrist, at Visit 2
Drug: Nitroglycerin 30mg · Drug: Lidocaine 20mg · Drug: Placebo
Lidocaine 40mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 40mg + placebo applied to the other wrist, at Visit 2
Drug: Nitroglycerin 30mg · Drug: Lidocaine 40mg · Drug: Placebo
15mg Nitroglycerin applied topically to one wrist
30mg Nitroglycerin applied topically to one wrist
20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo
40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo
Topical skin moisturizing cream with same appearance as active agent
Also known as: skin moisturizing cream
Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin
Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process.
Time frame: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 1
Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg)
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.
Time frame: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2
| Milestone | Dose-test 15mg | Dose-test 30mg | Combination Test 20mg | Combination Test 40mg |
|---|---|---|---|---|
| Started | 12 | 7 | 0 | 0 |
| Completed | 12 | 7 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Dose-test 15mg | Dose-test 30mg | Combination Test 20mg | Combination Test 40mg |
|---|---|---|---|---|
| Started | 0 | 0 | 10 | 9 |
| Completed | 0 | 0 | 10 | 9 |
| Not completed | 0 | 0 | 0 | 0 |
Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process.
| percent diameter change | Placebo | 15mg Nitroglycerin | 30mg Nitroglycerin |
|---|---|---|---|
| 10 minutes | -0.8 ± 0.5 | -0.2 ± 2.8 | 6.4 ± 4.5 |
| 30 minutes | 2.5 ± 12.5 | 0.8 ± 3.5 | 14.9 ± 18.1 |
| 60 minutes | 3.3 ± 6.5 | 10.2 ± 5.4 | 21.5 ± 6.6 |
| 120 minutes | 5.9 ± 6.5 | 8.8 ± 10.1 | 28.5 ± 12.1 |
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.
| percent diameter change | Lidocaine 20mg + Placebo | Lidocaine 20mg + Nitroglycerin 30mg | Lidocaine 40mg + Placebo | Lidocaine 40mg + Nitroglycerin 30mg |
|---|---|---|---|---|
| 10 minutes | 4 ± 3.6 | 4.9 ± 7.2 | 1.6 ± 3.0 | 3.4 ± 3.0 |
| 30 minutes | 5.3 ± 5.8 | 11.0 ± 10.6 | 2.9 ± 1.8 | 10.6 ± 6.5 |
| 60 minutes | 8.4 ± 7.4 | 18.2 ± 9.4 | 2.5 ± 3.2 | 17.2 ± 9.2 |
| 120 minutes | 5.7 ± 6.8 | 18.5 ± 8.7 | 4.1 ± 3.9 | 22.1 ± 12.0 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study | — | 0/19 (0%) | 0/19 (0%) |
The PI has left the institution and all efforts to locate per arm data for this module have been exhausted and therefore cannot be reported.
| Age, Categorical(Participants) | Overall Study |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 0 |
| Age, Continuous(years) | Overall Study |
|---|---|
| Mean | 29 ± 4 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 13 |
| Male | 6 |
| Region of Enrollment(participants) | Overall Study |
|---|---|
| United States | 19 |
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco