Radial Artery Spasm
Conditions
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.
Interventions
DRUGTransdermal glyceryl trinitrate 10mg patches
Transdermal patches applied to skin 30 minutes before cardiac catheterization
DRUGPlacebo patches
Transdermal placebo patches applied to skin 30 minutes before cardiac catheterization
Sponsors
Aristotle University Of Thessaloniki
424 General Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial Spasm occurrence | Immediately after the end of the procedure | Radial spasm is measured by the exerting force (in Newton) removing the sheath from the patient |
| Successful radial puncture | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VRS-4 pain scale | During the whole procedure | The pain during the procedure is measured by the four-category verbal rating scale (VRS-4) |
| State-Trait Anxiety Inventory (STAI) | During the whole procedure | The anxiety during the procedure is measured by the State - Trait Anxiety Inventory (STAI) |
Countries
Greece
Contacts
Primary ContactFotios Oikonomou, MD, PhD
Backup ContactIoannis Doundoulakis, MD
Outcome results
None listed