Overview
Safety and Tolerability of Nitro for Radial Artery Dilation
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-03-01
2023-03-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Early Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Thomas Jefferson UniversityTreatments:
Nitroglycerin
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