HealthyPhase 1NCT00686231
Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
A Phase 1 study testing Nitroglycerin 15mg, Nitroglycerin 30mg and Lidocaine 20mg in people with Healthy, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nitroglycerin 15mg, Nitroglycerin 30mg and Lidocaine 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Dec 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give written informed consent and comply with study requirements
- Patient who speak English
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center
San Francisco, California, 94143
About this study
Official title: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Nitroglycerin 15mg, Nitroglycerin 30mg, Lidocaine 20mg, Lidocaine 40mg, Placebo
- Keywords
- To determine if topical nitroglycerin acts to vasodilate the radial artery by a direct local action, or by systemic vasodilation, To determine if topical nitroglycerin dilates the radial artery in the presence of local anesthetic agents used in cardiac catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin 15mgDrug
15mg Nitroglycerin applied topically to one wrist
Nitroglycerin 30mgDrug
30mg Nitroglycerin applied topically to one wrist
Lidocaine 20mgDrug
20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo
Lidocaine 40mgDrug
40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo
PlaceboDrug
Also called skin moisturizing cream
Topical skin moisturizing cream with same appearance as active agent
| Study group | Role | What they receive |
|---|---|---|
| Dose Test 15mg NTG | Experimental | Nitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1 Receives: Drug: Nitroglycerin 15mg; Drug: Placebo |
| Dose Test 30mg NTG | Experimental | Nitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1 Receives: Drug: Nitroglycerin 30mg; Drug: Placebo |
| 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 Receives: Drug: Nitroglycerin 30mg; Drug: Lidocaine 20mg; Drug: Placebo |
| 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 Receives: Drug: Nitroglycerin 30mg; Drug: Lidocaine 40mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686231
- Sponsor's protocol ID
- 56438-31921
- Status last verified
- Mar 2020
- First submitted
- 19 May 2008
- Last updated
- 6 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22699036
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
- ClinicalTrials.gov ID
- NCT00686231
- Acronym / sponsor ID
- 56438-31921
- Conditions
- Healthy
- Keywords
- To determine if topical nitroglycerin acts to vasodilate the radial artery by a direct local action, or by systemic vasodilation, To determine if topical nitroglycerin dilates the radial artery in the presence of local anesthetic agents used in cardiac catheterization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 May 2008 (estimated)
- Results
- Posted 22 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Test 15mg NTG | Experimental | Drug: Nitroglycerin 15mg, Drug: PlaceboNitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1 |
| Dose Test 30mg NTG | Experimental | Drug: Nitroglycerin 30mg, Drug: PlaceboNitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1 |
| Combination Test 20mg Lidocaine | Experimental | Drug: Nitroglycerin 30mg, Drug: Lidocaine 20mg, Drug: PlaceboLidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the other wrist, at Visit 2 |
| Combination Test 40mg Lidocaine | Experimental | Drug: Nitroglycerin 30mg, Drug: Lidocaine 40mg, Drug: PlaceboLidocaine 40mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 40mg + placebo applied to the other wrist, at Visit 2 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Willing and able to give written informed consent and comply with study requirements
- Patient who speak English
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroglycerin 15mg15mg Nitroglycerin applied topically to one wrist | Drug | Dose Test 15mg NTG |
| Nitroglycerin 30mg30mg Nitroglycerin applied topically to one wrist | Drug | Combination Test 20mg Lidocaine, Combination Test 40mg Lidocaine, Dose Test 30mg NTG |
| Lidocaine 20mg20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo | Drug | Combination Test 20mg Lidocaine |
| Lidocaine 40mg40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo | Drug | Combination Test 40mg Lidocaine |
| PlaceboAlso: skin moisturizing creamTopical skin moisturizing cream with same appearance as active agent | Drug | Combination Test 20mg Lidocaine, Combination Test 40mg Lidocaine, Dose Test 15mg NTG, Dose Test 30mg NTG |
Primary outcome
Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin
Time frame: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 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.
Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg)
Time frame: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22699036Majure 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nitroglycerin 15mg, Nitroglycerin 30mg and Lidocaine 20mg in people with Healthy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin (time frame: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00686231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.