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Radial Artery SpasmPhase 3NCT06912139

Topical Nitroglycerine for Prevention of Radial Artery Spasm

A Phase 3 study testing Nitroglycerin transdermal in people with Radial Artery Spasm, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Radial Artery Spasm
What is being tested?
Nitroglycerin transdermal
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteRomania
Study dates
1 Apr 2023to 30 Jun 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Romania1 site
  • Timisoara Institute for Cardiovascular Diseases

    Timișoara, Timiș County, 300134

Other trials in Romania

About this study

Official title: 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

Read the 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).

Being tested
Nitroglycerin transdermal, Placebo
Keywords
topical nitroglycerine, radial artery spasm, coronary angiography, radial puncture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitroglycerin transdermalDrug

    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.

  • PlaceboOther

    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.

Study groups in NCT06912139
Study groupRoleWhat they receive
nitroglycerin topic cream for radial artery spasm prevention, applied before radial artery punctureActive comparatorNot described
Receives: Drug: Nitroglycerin transdermal
placebo cream administrationPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline

Secondary outcomes (11)
  1. 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

    Measured: Baseline

  2. 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

    Measured: Baseline

  3. Radial artery diameter, absolute value

    Angiographical measurement of radial artery diameter in non-spastic area

    Measured: Baseline

  4. 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

    Measured: Intraprocedural, every 15 minutes

  5. 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

    Measured: Baseline

  6. Contrast medium used during procedure

    Total amount in milliliters l is noted

    Measured: At the end of invasive procedure

  7. Invasive procedure duration

    Total duration of procedure is noted, from puncture of artery to catheter withdrawal (coronary angiography, angioplasty, other angiographic investigation)

    Measured: at the end of invasive procedure

  8. Hospital stay duration

    Total length of hospitalization is noted (in days)

    Measured: Up to 10 weeks

  9. 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

    Measured: Up to 3 weeks

  10. 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

    Measured: Up to 3 weeks

  11. Radial artery diameter indexed to body surface area

    Angiographical measurement of radial artery diameter in non-spastic area indexed to patient body surface area

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start1 Apr 2023
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06912139
Sponsor's protocol ID
11/10.03.2023
Status last verified
Mar 2025
First submitted
20 Mar 2025
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nitroglycerin transdermal in people with Radial Artery Spasm, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radial artery spasm as determined by angiography of radial artery; spasm being defined as >50% stenosis (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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