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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Test 15mg NTG | Experimental | Nitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1 |
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| Dose Test 30mg NTG | Experimental | Nitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1 |
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| Combination Test 20mg Lidocaine | Experimental | Lidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the other wrist, at Visit 2 |
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| Combination Test 40mg Lidocaine | Experimental | Lidocaine 40mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 40mg + placebo applied to the other wrist, at Visit 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin 15mg | Drug | 15mg Nitroglycerin applied topically to one wrist |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22699036 | Derived | Majure DT, Hallaux M, Yeghiazarians Y, Boyle AJ. Topical nitroglycerin and lidocaine locally vasodilate the radial artery without affecting systemic blood pressure: a dose-finding phase I study. J Crit Care. 2012 Oct;27(5):532.e9-13. doi: 10.1016/j.jcrc.2012.04.019. Epub 2012 Jun 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose-test 15mg | 15mg Nitroglycerin on one wrist and Placebo on the other |
| FG001 | Dose-test 30mg | 30mg Nitroglycerin on one wrist and Placebo on the other |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Test - Visit 1 |
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| Nitroglycerin 30mg |
| Drug |
30mg Nitroglycerin applied topically to one wrist |
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| Lidocaine 20mg | Drug | 20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo |
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| Lidocaine 40mg | Drug | 40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo |
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| Placebo | Drug | Topical skin moisturizing cream with same appearance as active agent |
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| FG002 | Combination Test 20mg | 30mg Nitroglycerin + 20mg Lidocaine on one wrist, and Placebo + 20mg Lidocaine on the other wrist |
| FG003 | Combination Test 40mg | 30mg Nitroglycerin + 40mg Lidocaine on one wrist, and Placebo + 40mg Lidocaine on the other |
| COMPLETED |
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| NOT COMPLETED |
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| Combination Test - Visit 2 |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 19 participants were randomized to receive 15mg (n=12) or 30mg (n=7) nitroglycerin on one wrist, and placebo on the other | Posted | Mean | Standard Deviation | percent diameter change | Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 1 | radial artery (wrist) | radial artery (wrist) |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percent diameter change | Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2 | Radial Artery | Radial Artery |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study | 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. | 0 | 19 | 0 | 19 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Boyle | UCSF | 415-514-0827 | aboyle@medicine.ucsf.edu |
| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| 60 minutes |
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| 120 minutes |
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40mg combination test: lidocaine + placebo |
| OG003 | Lidocaine 40mg + Nitroglycerin 30mg | 40mg combination test: lidocaine + nitroglycerin |
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