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Artery; DilatationEarly Phase 1RADialNCT05239013

Safety and Tolerability of Nitro for Radial Artery Dilation

A Early Phase 1 study testing Nitroglycerin ointment in people with Artery; Dilatation, run by Thomas Jefferson University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Phase 1, single-center, open-label clinical study to assess the safety and efficacy of topical nitroglycerin on dilation of the radial artery. Subjects will receive nitroglycerin ointment prior to scheduled PCI and radial artery measurements will be performed to determine mean increase in radial artery diameter at… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Artery; Dilatation
What is being tested?
Nitroglycerin ointment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 May 2022to 1 Mar 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory

Who cannot join

  • Known nitrate allergy
  • Baseline hypotension with systolic blood pressure <90mmHg
  • Absence of radial artery blood flow in one or both arms
  • Presence or history of liver, rheumatologic, or chronic kidney disease
  • Current treatment with any vasodilator therapy (eg. Sildenafil)
  • Radial artery catheterization <30 days prior to enrollment
Show all 9Show fewer
  • Active site infection
  • AV-fistula or prior radial artery harvest for bypass surgery
  • Abnormal Barbeau test

Trial locations and contacts

No sites are listed yet.

Michael W Foster, M.D. contact

6107160962

mxf314@jefferson.edu

Waqas Ullah, M.D. contact

waqas.ullah@jefferson.edu

About this study

Official title: Safety and Tolerability of Topical Nitroglycerin to Dilate the Radial Artery Prior to Transradial Coronary Angiography

Phase 1, single-center, open-label clinical study to assess the safety and efficacy of topical nitroglycerin on dilation of the radial artery. Subjects will receive nitroglycerin ointment prior to scheduled PCI and radial artery measurements will be performed to determine mean increase in radial artery diameter at several time points. There will be 20 subjects enrolled in this study.

Read the detailed description

This is a phase I study evaluating the safety, tolerability, and efficacy of topical nitroglycerin prior to percutaneous coronary intervention (PCI). Although the ultimate plan is to evaluate this intervention vs placebo, it is important to first determine whether topical nitroglycerin not only is safe for patients, but whether it effectively dilates the radial artery. Given that patients who receive topical nitroglycerin applied to the chest for other reasons (angina or acute coronary syndrome, hypertension, etc) have reported headaches and/or have experienced decreased blood pressure, it is important to determine whether these noted side effects are present when nitroglycerin ointment is applied to the arm. Prior to initiating any study procedures, we will perform a Barbeau test to determine normal blood flow through the radial artery and collateral circulation from the ulnar artery through the palmar arch. After the ointment is applied, we will also be measuring the dimensions of the radial artery for the degree of dilation in order to determine whether topical nitroglycerin is indeed a possible method for increasing the rate of PCI performed using the transradial approach (TRA).

Being tested
Nitroglycerin ointment
Keywords
cardiac catheterization, transradial approach, nitroglycerin
Medical subject headings
Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitroglycerin ointmentDrug

    Also called Nitropaste

    2 cm (30mg) of 2% nitroglycerin applied 2 cm from the styloid process of the anterior forearm

Study groups in NCT05239013
Study groupRoleWhat they receive
Treatment GroupExperimentalSubjects who receive the intervention
Receives: Drug: Nitroglycerin ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in systolic blood pressure

    Changes in blood pressure measured by upper arm cuff pressure

    Measured: 45 minutes

  2. Incidence of headache

    Rate and severity of headache, determined by subject-reported symptoms.

    Measured: 45 minutes

  3. Hematoma

    Incidence of forearm hematoma development

    Measured: 45 minutes

Secondary outcomes (3)

  1. Radial artery dilation

    Change in radial artery dilation, measured by radial artery diameter using high-frequency (13MHz) linear array transducer 2cm proximal to the radial styloid process at 15 and 30 minute time points.

    Measured: 45 minutes

  2. Punctures required

    Number of radial artery punctures/attempts

    Measured: 45 minutes

  3. Transradial conversions to transfemoral approach

    Number of conversions to transfemoral approach

    Measured: 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start1 May 2022 (estimated)
  3. Primary completion1 Mar 2023 (estimated)
  4. Study completion1 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05239013
Sponsor's protocol ID
RADial
Acronym
RADial
Status last verified
Mar 2022
First submitted
7 Feb 2022
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: To be decided

Publications

  • Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, Ports TA, Boyle AJ. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol. 2013 Oct 3;168(3):2575-8. doi: 10.1016/j.ijcard.2013.03.048. Epub 2013 Apr 10.

    PubMed 23582415

  • Caputo RP, Tremmel JA, Rao S, Gilchrist IC, Pyne C, Pancholy S, Frasier D, Gulati R, Skelding K, Bertrand O, Patel T. Transradial arterial access for coronary and peripheral procedures: executive summary by the Transradial Committee of the SCAI. Catheter Cardiovasc Interv. 2011 Nov 15;78(6):823-39. doi: 10.1002/ccd.23052. Epub 2011 May 4.

    PubMed 21544927

  • Divakaran S, Loscalzo J. The Role of Nitroglycerin and Other Nitrogen Oxides in Cardiovascular Therapeutics. J Am Coll Cardiol. 2017 Nov 7;70(19):2393-2410. doi: 10.1016/j.jacc.2017.09.1064.

    PubMed 29096811

  • Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1.

    PubMed 19081409

  • 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

  • Manoukian SV, Feit F, Mehran R, Voeltz MD, Ebrahimi R, Hamon M, Dangas GD, Lincoff AM, White HD, Moses JW, King SB 3rd, Ohman EM, Stone GW. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial. J Am Coll Cardiol. 2007 Mar 27;49(12):1362-8. doi: 10.1016/j.jacc.2007.02.027. Epub 2007 Mar 9.

    PubMed 17394970

  • Riegel B, Heywood G, Jackson W, Kennedy A. Effect of nitroglycerin ointment placement on the severity of headache and flushing in patients with cardiac disease. Heart Lung. 1988 Jul;17(4):426-31.

    PubMed 3134314

  • Wester RC, Noonan PK, Smeach S, Kosobud L. Pharmacokinetics and bioavailability of intravenous and topical nitroglycerin in the rhesus monkey: estimate of percutaneous first-pass metabolism. J Pharm Sci. 1983 Jul;72(7):745-8. doi: 10.1002/jps.2600720708.

    PubMed 6411893

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Nitroglycerin ointment in people with Artery; Dilatation, run by Thomas Jefferson University.

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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael W Foster, M.D. (6107160962, mxf314@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in systolic blood pressure (time frame: 45 minutes). The study lists 3 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 NCT05239013, which also lists 8 linked publications.

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 Apr 2022.

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