Safety and Tolerability of Nitro for Radial Artery Dilation

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Artery; Dilatation

Intervention / Treatment
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* Drug: Nitroglycerin ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Subjects who receive the intervention | Drug: Nitroglycerin ointment<br>* 2 cm (30mg) of 2% nitroglycerin applied 2 cm from the styloid process of the anterior forearm<br>* Other names: Nitropaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 45 minutes | 
| Punctures required | Number of radial artery punctures/attempts | 45 minutes | 
| Transradial conversions to transfemoral approach | Number of conversions to transfemoral approach | 45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac catheterization, transradial approach, nitroglycerin