Topical Nitroglycerine for Prevention of Radial Artery Spasm

Topical Nitroglycerin Pretreatment for the Prevention of Radial Arterial Spasm

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

Study Overview

• Status: Completed
• Conditions: Radial Artery Spasm
• Intervention / Treatment: Drug: Nitroglycerin transdermal; Other: Placebo

Detailed Description

During the period of April 2023 - June 2023, 100 consecutive patients that un-derwent invasive angiography using radial artery approach (deemed suitable access site by operating physician) were enrolled and randomized to either pretreatment with a topical cream 0.2% NTG, or application of a gel that contained no active substances. Randomization was done using a computer program designed to randomly produce either the digit 1 or 0, with 1 meaning the patient was assigned to nitroglycerine cohort and 0 to placebo cohort. The assigned nurse that handled the randomization also ad-ministered the patient's treatment. The NTG or placebo cream was applied 20-40 minutes before radial artery puncture by the assigned nurse. The study was designed as a randomized, double-blinded trial, with neither the patient nor the operator aware of the treatment allocation. Patients had indication of either elective or emergency coronary artery or peripheral artery angiography, and had no contraindication to ra-dial artery approach. Both right and left radial arteries were used, depending on oper-ator judgement, while distal radial approach was not utilized in any case. The operator assessed the radial artery pulse quality by manual palpation before puncture. Standard local subcutaneous anesthesia with 5 ml of 2% lidocaine solution was performed. A visual analog scale was used to judge patient discomfort related to the puncture and puncture site at several times during the procedure, with the worst pain level being documented (scale of 0 to 10, where 0 is no pain, and 10 is worst possible pain). The key objective was assessing spasm of the radial artery, which was judged both subjectively by the operator by judging the grade of resistance felt during manipulation of the catheters, and objectively by injection of contrast dye into the radial artery through the introducer sheath immediately after it had been placed inside the radial artery. Spasm was defined as narrowing of the radial artery lumen by more than 50%. Diffuse spasm was defined as spasm of a segment of radial artery greater than 2 cm, or more than two different sites of spasm. The diameter of the radial artery was also measured on the radial angiograms, and was indexed to the patient's body surface area. After sheath insertion and radial artery measurement, the operator could administer intraarterial NTG at his discretion throughout the procedure.

Other data that was included was number of attempts that lead to successful puncture and sheath placement, procedure duration (including angioplasty if needed), contrast dye used and hospital stay duration. Patients were screened for cardiovascu-lar risk factors such as smoking, diabetes mellitus, dyslipidemia, hypertension and obesity. Procedural anticoagulation was performed using 5000 units of unfractioned heparin for diagnostic procedures and 70 units/kilogram for angioplasties. At the end of the procedure, after sheath extraction, hemostasis was achieved using a compres-sive dressing that was left in place for ~12 hours. Bleeding complications at the site of puncture were noted (presence of local hematoma), and ultrasound screening at dis-charge was used to check postprocedural radial artery patency.

Radial sheaths used were 6 French, and the operator had the freedom to use any size of catheters he considered, most often choosing 6 French for both diagnostic angi-ography and percutaneous intervention. No preprocedural patient sedation was used, and cath lab temperature was similar for all cases.

Statistical analysis was performed using IBM SPSS Statistics version 20.0 software for Windows with a significant p<0.05. We used descriptive statistics, figures, and ta-bles to summarize our findings. Results for targeted variables were presented using descriptive statistics (mean, standard deviation, range, median, and associated inter-quartile range) for continuous data, and counts with associated percentages for cate-gorical data. Independent samples t-test was used to analyze differences in means for continuous variables, while differences between categorical variables were examined by Chi-squared test. Categorical data are presented as counts (percentages).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Romania
  • Timis
    • Timisoara, Timis, Romania, 300134
      • Timisoara Institute for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nitroglycerin topic cream for radial artery spasm prevention, applied before radial artery puncture	Drug: Nitroglycerin transdermal; 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.
Placebo Comparator: placebo cream administration	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radial artery spasm as determined by angiography of radial artery; spasm being defined as >50% stenosis	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of radial artery puncture attempts	Nitroglycerin cream is applied ~15 minutes before radial puncture is attempted, operator notes number of tries to successfully puncture it and place the sheath	Baseline
Crossover to alternative puncture site	If radial puncture is unsuccessful another puncture site is needed, this is noted by operator as need for cross-over	Baseline
Radial artery diameter, absolute value	Angiographical measurement of radial artery diameter in non-spastic area	Baseline
Patient discomfort measured using a Visual Analog Scale	The patient is asked throughout the procedure level of pain on a 0-10 scale, and maximum level is noted	Intraprocedural, every 15 minutes
Radial artery spasm: diffuse or localized	If radial spasm is present on a segment of radial artery longer than 20mm it is noted as diffuse, if shorter then it is noted as localized	Baseline
Contrast medium used during procedure	Total amount in milliliters l is noted	At the end of invasive procedure
Invasive procedure duration	Total duration of procedure is noted, from puncture of artery to catheter withdrawal (coronary angiography, angioplasty, other angiographic investigation)	at the end of invasive procedure
Hospital stay duration	Total length of hospitalization is noted (in days)	Up to 10 weeks
Number of patients with radial artery patency at discharge	Radial artery patency (of punctured artery) is determined by ultrasound analysis on the day of discharge	Up to 3 weeks
Local complications at puncture site - hematoma	During hospital stay, after procedure is completed, forearm is examined for local hematoma in relation to radial artery puncture site	Up to 3 weeks
Radial artery diameter indexed to body surface area	Angiographical measurement of radial artery diameter in non-spastic area indexed to patient body surface area	Baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: coronary angiography; radial artery spasm; topical nitroglycerine; radial puncture
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Neuromuscular Manifestations; Peripheral Vascular Diseases; Spasm; Muscle Cramp; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: 11/10.03.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No