Safety and Tolerability of Nitro for Radial Artery Dilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ultrasound Evaluation of Lower Extremity Arteries After Topical Nitroglycerin Administration

NCT04155476

Peripheral Arterial Disease

UNKNOWN EARLY_PHASE1

MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects

NCT00513994

Healthy

COMPLETED PHASE1

A Prospective Study to Evaluate the Effect of Chronic Nitrate Therapy on Vasodilation Function in Coronary Heart Disease

NCT01430780

Coronary Artery Disease

UNKNOWN

Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.

NCT02258620

Coronaropathy

COMPLETED NA

Dietary Nitrate and Nitrite to Increase Nitric Oxide in Patients With Coronary Artery Disease

NCT00069654

Coronary Arteriosclerosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Artery; Dilatation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

Subjects who receive the intervention

Group Type EXPERIMENTAL

Nitroglycerin ointment

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nitroglycerin ointment

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nitropaste

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes