Nitrate Use to Obtain Radial Spasm Embarrassment (NURSE - TTS Trial)

Study Overview
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Brief Summary
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Transradial cardiac catheterization and percutaneous coronary intervention are increasingly being performed worldwide in elective and emergency procedures, with many centres adopting the transradial route as their first choice of arterial access. One of the most common complications encountered during transradial procedures is radial artery spasm. The aim of this study is to evaluate the Efficacy and Safety of the use of transdermal Glyceryl trinitrate patches applied to skin before cardiac catheterization to prevent the occurrence of radial artery spasm during transradial access cardiac catheterization.

Official Title
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A Randomised, Double-blind, Parallel Group, Efficacy and Safety Study of Transdermal Patch Nitroglycerin in the Prevention of Coronary Artery Spasm, During Coronary Angiography/ Angioplasty (NURSE-TTS - Nitrate Use to Obtain Radial Spasm Embarrassment)

Conditions
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Radial Artery Spasm

Intervention / Treatment
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* Drug: Transdermal glyceryl trinitrate 10mg patches
* Drug: Placebo patches


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 -85 years old who has been admitted for scheduled coronary angiography by radial artery Exclusion Criteria: Prior same radial artery catheterization Positive Allen test Severe Hypotension (SBP<100 mmHg) Pregnancy Ongoing Acute Myocardial Infarction Ongoing cardiogenic shock Known History of Nitrates intolerance/allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdermal glyceryl trinitrate patches<br> | Drug: Transdermal glyceryl trinitrate 10mg patches<br>* Transdermal patches applied to skin 30 minutes before cardiac catheterization<br>* Other names: Nitrong tts 10mg- Lavipharm S.A.;|
| Placebo Comparator: Transdermal placebo patches<br> | Drug: Placebo patches<br>* Transdermal placebo patches applied to skin 30 minutes before cardiac catheterization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial Spasm occurrence | Radial spasm is measured by the exerting force (in Newton) removing the sheath from the patient | Immediately after the end of the procedure | 
| Successful radial puncture | The success is defined by the fast radial puncture and catheterization and is measured by the time of radial catheterization | During radial puncture and catheterization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VRS-4 pain scale | The pain during the procedure is measured by the four-category verbal rating scale (VRS-4) | During the whole procedure | 
| State-Trait Anxiety Inventory (STAI) | The anxiety during the procedure is measured by the State - Trait Anxiety Inventory (STAI) | During the whole procedure |