Status:

UNKNOWN

Safety and Tolerability of Nitro for Radial Artery Dilation

Lead Sponsor:

Thomas Jefferson University

Conditions:

Artery; Dilatation

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

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 sch...

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 int...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

May 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2023

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05239013

Start Date

May 1 2022

End Date

March 1 2023

Last Update

April 6 2022

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