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| Name | Class |
|---|---|
| Aristotle University Of Thessaloniki | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdermal glyceryl trinitrate patches | Experimental |
| |
| Transdermal placebo patches | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal glyceryl trinitrate 10mg patches | Drug | Transdermal patches applied to skin 30 minutes before cardiac catheterization |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fotios Oikonomou, MD, PhD | Contact | 00306977618318 | economouf@gmail.com | |
| Ioannis Doundoulakis, MD | Contact | 00306946002830 | doudougiannis@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 424 GeneralMH | Recruiting | Thessaloniki | 56429 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36609046 | Derived | Economou FI, Doundoulakis I, Kalamakidou I, Koliastasis L, Soulaidopoulos S, Samara M, Dimitriadis K, Papazisis G, Tsiachris D, Tsioufis K. Prevention of Radial Artery Spasm With Transdermal Glyceryl Trinitrate Patches: The NURSE-TTS Randomized Study. JACC Cardiovasc Interv. 2023 Feb 13;16(3):365-367. doi: 10.1016/j.jcin.2022.09.032. Epub 2023 Jan 4. No abstract available. |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
| Placebo patches | Drug | Transdermal placebo patches applied to skin 30 minutes before cardiac catheterization |
|
| During the whole procedure |