Safety and Tolerability of Nitro for Radial Artery Dilation

NCT05239013 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: RADial
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 several time points. There will be 20 subjects enrolled in this study.

Conditions

Artery; Dilatation

Keywords

cardiac catheterization; transradial approach; nitroglycerin

Outcome Measures

Primary Outcomes (3)

• Change in systolic blood pressure

  Changes in blood pressure measured by upper arm cuff pressure

  45 minutes

• Incidence of headache

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

  45 minutes

• Hematoma

  Incidence of forearm hematoma development

  45 minutes

Secondary Outcomes (3)

• Radial artery dilation

  45 minutes

• Punctures required

  45 minutes

• Transradial conversions to transfemoral approach

  45 minutes

Study Arms (1)

Treatment Group

EXPERIMENTAL

Subjects who receive the intervention

Drug: Nitroglycerin ointment

Interventions

Nitroglycerin ointment DRUG

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

Also known as: Nitropaste

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Active site infection
• AV-fistula or prior radial artery harvest for bypass surgery
• Abnormal Barbeau test

Sponsors & Collaborators

• Thomas Jefferson University: lead

Related Publications (8)

• 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.

  PMID: 23582415 BACKGROUND

• 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.

  PMID: 21544927 BACKGROUND

• 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.

  PMID: 29096811 BACKGROUND

• 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.

  PMID: 19081409 BACKGROUND

• 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.

  PMID: 22699036 BACKGROUND

• 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.

  PMID: 17394970 BACKGROUND

• 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.

  PMID: 3134314 BACKGROUND

• 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.

  PMID: 6411893 BACKGROUND

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Fischman, M.D.

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael W Foster, M.D.

CONTACT

6107160962; mxf314@jefferson.edu

Waqas Ullah, M.D.

CONTACT

waqas.ullah@jefferson.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 14, 2022
• Study Start: May 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-03