Topical Nitro or Placebo Pre-Cath

Coronary Artery Disease Clinical Trial

Official title:

Topical Nitroglycerin Prior to Trans-radial Coronary Angiography: a Phase 2, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06289946
• Other study ID #: NitroRadialLHC
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Thomas Jefferson University
• Contact: Michael w Foster, MD
• Phone: 6107160962
• Email: mxf314[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization.

Description:

Percutaneous coronary intervention (PCI) procedures performed by entering the radial artery, or the transradial approach (TRA), is associated with reduced vascular access site complications, bleeding, and length of hospital stay, as well as greater patient satisfaction when compared to the transfemoral approach. One of the major challenges to a successful TRA remains the small size of the radial artery. The potential need for larger catheters during PCI has been one factor limiting broader adoption of TRA and a common reason for crossover from TRA to femoral access intraprocedurally. Additionally, multiple unsuccessful attempts to access the radial artery leads to unnecessary bleeding and may lead to severe arterial vasospasms. Nitroglycerin, a vasodilator, is available in a topical form and may be used prior to PCI to dilate the radial artery and potentially increase the rate of successful TRA.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: March 31, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or non-pregnant female > 18 years of age at the time of consent

2. Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory

3. Able to provide informed consent with capacity, given in English.

Exclusion Criteria

Patients with any of the following characteristics or conditions will not be included in the study:

1. Known nitrate allergy

2. Allergy to CeraVe Moisturizing lotion

3. Baseline hypotension with systolic blood pressure <90mmHg

4. Absence of radial artery blood flow in one or both arms

5. Presence or history of liver, rheumatologic, or chronic kidney disease

6. Current treatment with any vasodilator therapy (eg. Sildenafil)

7. Radial artery catheterization <30 days prior to enrollment

8. Active site infection

9. AV-fistula or prior radial artery harvest for bypass surgery

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• NitroBid
We will apply nirobid to the wrist prior to left heart catheterization.
• Placebo
We will apply placebo moisturizing cream to the wrist

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crossover rate	• Evaluate number of attempts needed prior to successful radial artery cannulation and need for conversion to transfemoral approach	1 year