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)
Overview
- Phase
- Phase 3
- Intervention
- Transdermal glyceryl trinitrate 10mg patches
- Conditions
- Radial Artery Spasm
- Sponsor
- 424 General Military Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Successful radial puncture
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Fotios Oikonomou
Consultant Interventional Cardiologist - Head of Cath Lab
424 General Military Hospital
Eligibility Criteria
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
Arms & Interventions
Transdermal glyceryl trinitrate patches
Intervention: Transdermal glyceryl trinitrate 10mg patches
Transdermal placebo patches
Intervention: Placebo patches
Outcomes
Primary Outcomes
Successful radial puncture
Time Frame: During radial puncture and catheterization
The success is defined by the fast radial puncture and catheterization and is measured by the time of radial catheterization
Radial Spasm occurrence
Time Frame: Immediately after the end of the procedure
Radial spasm is measured by the exerting force (in Newton) removing the sheath from the patient
Secondary Outcomes
- State-Trait Anxiety Inventory (STAI)(During the whole procedure)
- VRS-4 pain scale(During the whole procedure)