Topical Nitroglycerine for Prevention of Radial Artery Spasm

NCT06912139 | Completed Phase 3

• 1 other identifier: 11/10.03.2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In a randomized, double-blind trial, 100 patients undergoing angiography were pre-treated with either topical nitroglycerin (NTG) or placebo. Outcomes assessed included radial artery spam (RAS) incidence, radial artery puncture success, number of attempts, procedural duration, patient discomfort, and complications. RAS was evaluated angiographically and clinically, with additional subgroup analyses for diabetic and smoking patients

Conditions

Radial Artery Spasm

Keywords

topical nitroglycerine; radial artery spasm; coronary angiography; radial puncture

Outcome Measures

Primary Outcomes (1)

• Radial artery spasm as determined by angiography of radial artery; spasm being defined as >50% stenosis

  Baseline

Secondary Outcomes (11)

• Number of radial artery puncture attempts

  Baseline

• Crossover to alternative puncture site

  Baseline

• Radial artery diameter, absolute value

  Baseline

• Patient discomfort measured using a Visual Analog Scale

  Intraprocedural, every 15 minutes

• Radial artery spasm: diffuse or localized

  Baseline

Study Arms (2)

nitroglycerin topic cream for radial artery spasm prevention, applied before radial artery puncture

ACTIVE COMPARATOR

Drug: Nitroglycerin transdermal

placebo cream administration

PLACEBO COMPARATOR

Other: Placebo

Interventions

Nitroglycerin transdermal DRUG

Nitroglycerin cream is applied \~ 15 minutes before radial artery puncture for emergency or planned invasive cardiology procedure (example: coronary angiography), and radial artery spasm and diameter are determined by angiography, injecting contrast into the radial artery through the placed radial sheath.

nitroglycerin topic cream for radial artery spasm prevention, applied before radial artery puncture

Placebo OTHER

Placebo cream with no active compounds is applied by the designated nurse to the radial puncture site, similar to NTG cream, with both patient and invasive cardiologist blinded wo which arm the patient is included in.

placebo cream administration

Eligibility Criteria

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

You may qualify if:

• indication for invasive cardiology procedure (diagnostic or curative)
• deemed suitable for radial access by operating physician

You may not qualify if:

• refuses or unable to give consent
• demed unsuitable for radial artery access (no radial pulse, small patient size, anticipation of complex procedure that requires alternative access site)

Sponsors & Collaborators

• University of Medicine and Pharmacy "Victor Babes" Timisoara: lead

Study Sites (1)

Timisoara Institute for Cardiovascular Diseases

Timișoara, Timiș County, 300134, Romania

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Legal entity appointed representative

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)