Topical Nitro or Placebo Pre-Cath

NCT06289946 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NitroRadialLHC
• Study Type: interventional
• Target: 256
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Crossover rate

  • Evaluate number of attempts needed prior to successful radial artery cannulation and need for conversion to transfemoral approach

  1 year

Study Arms (2)

Placebo arm

PLACEBO COMPARATOR

Subject will get placebo

Drug: Placebo

Nitro arm

EXPERIMENTAL

Subject will get Nitrobid

Drug: NitroBid

Interventions

NitroBid DRUG

We will apply nirobid to the wrist prior to left heart catheterization.

Nitro arm

Placebo DRUG

We will apply placebo moisturizing cream to the wrist

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female \> 18 years of age at the time of consent
• Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory
• Able to provide informed consent with capacity, given in English.

You may not qualify if:

• Patients with any of the following characteristics or conditions will not be included in the study:
• Known nitrate allergy
• Allergy to CeraVe Moisturizing lotion
• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Central Study Contacts

Michael w Foster, MD

CONTACT

6107160962; mxf314@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 31, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-02