Nitrate Use to Obtain Radial Spasm Embarrassment (NURSE - TTS Trial) (NURSE-TTS)
Primary Purpose
Radial Artery Spasm
Status
Unknown status
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Transdermal glyceryl trinitrate 10mg patches
Placebo patches
Sponsored by
About this trial
This is an interventional prevention trial for Radial Artery Spasm
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
Sites / Locations
- 424 GeneralMHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Transdermal glyceryl trinitrate patches
Transdermal placebo patches
Arm Description
Outcomes
Primary Outcome Measures
Radial Spasm occurrence
Radial spasm is measured by the exerting force (in Newton) removing the sheath from the patient
Successful radial puncture
The success is defined by the fast radial puncture and catheterization and is measured by the time of radial catheterization
Secondary Outcome Measures
VRS-4 pain scale
The pain during the procedure is measured by the four-category verbal rating scale (VRS-4)
State-Trait Anxiety Inventory (STAI)
The anxiety during the procedure is measured by the State - Trait Anxiety Inventory (STAI)
Full Information
NCT ID
NCT04766151
First Posted
February 15, 2021
Last Updated
February 20, 2021
Sponsor
424 General Military Hospital
Collaborators
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT04766151
Brief Title
Nitrate Use to Obtain Radial Spasm Embarrassment (NURSE - TTS Trial)
Acronym
NURSE-TTS
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
424 General Military Hospital
Collaborators
Aristotle University Of Thessaloniki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Artery Spasm
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transdermal glyceryl trinitrate patches
Arm Type
Experimental
Arm Title
Transdermal placebo patches
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Transdermal glyceryl trinitrate 10mg patches
Other Intervention Name(s)
Nitrong tts 10mg- Lavipharm S.A.
Intervention Description
Transdermal patches applied to skin 30 minutes before cardiac catheterization
Intervention Type
Drug
Intervention Name(s)
Placebo patches
Intervention Description
Transdermal placebo patches applied to skin 30 minutes before cardiac catheterization
Primary Outcome Measure Information:
Title
Radial Spasm occurrence
Description
Radial spasm is measured by the exerting force (in Newton) removing the sheath from the patient
Time Frame
Immediately after the end of the procedure
Title
Successful radial puncture
Description
The success is defined by the fast radial puncture and catheterization and is measured by the time of radial catheterization
Time Frame
During radial puncture and catheterization
Secondary Outcome Measure Information:
Title
VRS-4 pain scale
Description
The pain during the procedure is measured by the four-category verbal rating scale (VRS-4)
Time Frame
During the whole procedure
Title
State-Trait Anxiety Inventory (STAI)
Description
The anxiety during the procedure is measured by the State - Trait Anxiety Inventory (STAI)
Time Frame
During the whole procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fotios Oikonomou, MD, PhD
Phone
00306977618318
Email
economouf@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ioannis Doundoulakis, MD
Phone
00306946002830
Email
doudougiannis@gmail.com
Facility Information:
Facility Name
424 GeneralMH
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fotios Oikonomou, MD, PhD
Phone
+306977618318
Email
economouf@gmail.com
First Name & Middle Initial & Last Name & Degree
Fotios Oikonomou, MD, Phd
First Name & Middle Initial & Last Name & Degree
Ioannis Doundoulakis, MD
First Name & Middle Initial & Last Name & Degree
Myrto Samara, MD, PhD
First Name & Middle Initial & Last Name & Degree
Iliada Kalamakidou, RN
First Name & Middle Initial & Last Name & Degree
Georgios Papazisis, MD, Phd
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nitrate Use to Obtain Radial Spasm Embarrassment (NURSE - TTS Trial)
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