Safety and Tolerability of Nitro for Radial Artery Dilation

Early Phase 1

• Conditions: Artery; Dilatation
• Interventions: Drug: Nitroglycerin ointment

• Registration Number: NCT05239013
• Lead Sponsor: Thomas Jefferson University

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).

Study Timeline

• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-14
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06
• Study Start: 2022-05-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Nitroglycerin ointment	Subjects who receive the intervention

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure	45 minutes	Changes in blood pressure measured by upper arm cuff pressure
Incidence of headache	45 minutes	Rate and severity of headache, determined by subject-reported symptoms.
Hematoma	45 minutes	Incidence of forearm hematoma development

Secondary Outcome Measures

Name	Time	Method
Radial artery dilation	45 minutes	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.
Transradial conversions to transfemoral approach	45 minutes	Number of conversions to transfemoral approach
Punctures required	45 minutes	Number of radial artery punctures/attempts