Clinical trial NCT05239013: Safety and Tolerability of Nitro for Radial Artery Dilation
Official title: Safety and Tolerability of Topical Nitroglycerin to Dilate the Radial Artery Prior to Transradial Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Artery; Dilatation
Keywords: cardiac catheterization
transradial approach
nitroglycerin
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in systolic blood pressure
timeFrame: 45 minutes
measure: Incidence of headache
timeFrame: 45 minutes
measure: Hematoma
timeFrame: 45 minutes
Secondary outcomes:
measure: Radial artery dilation
timeFrame: 45 minutes
measure: Punctures required
timeFrame: 45 minutes
measure: Transradial conversions to transfemoral approach
timeFrame: 45 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Thomas Jefferson University
name: David Fischman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.