Radial Artery SpasmPhase 3NURSE-TTSNCT04766151
Nitrate Use to Obtain Radial Spasm Embarrassment (NURSE - TTS Trial)
A Phase 3 study testing Transdermal glyceryl trinitrate 10mg patches in people with Radial Artery Spasm, run by 424 General Military Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Radial Artery Spasm
- What is being tested?
- Transdermal glyceryl trinitrate 10mg patches
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2021to 30 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 -85 years old who has been admitted for scheduled coronary angiography by radial artery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
424 GeneralMH
Thessaloniki, 56429
Fotios Oikonomou, MD, PhD, +306977618318, economouf@gmail.com
Fotios Oikonomou, MD, Phd
About this study
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)
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.
- Conditions
- Radial Artery Spasm
- Being tested
- Transdermal glyceryl trinitrate 10mg patches, Placebo patches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal glyceryl trinitrate 10mg patchesDrug
Also called Nitrong tts 10mg- Lavipharm S.A.
Transdermal patches applied to skin 30 minutes before cardiac catheterization
Placebo patchesDrug
Transdermal placebo patches applied to skin 30 minutes before cardiac catheterization
| Study group | Role | What they receive |
|---|---|---|
| Transdermal glyceryl trinitrate patches | Experimental | Not described Receives: Drug: Transdermal glyceryl trinitrate 10mg patches |
| Transdermal placebo patches | Placebo comparator | Not described Receives: Drug: Placebo patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial Spasm occurrence
Radial spasm is measured by the exerting force (in Newton) removing the sheath from the patient
Measured: 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
Measured: During radial puncture and catheterization
Secondary outcomes (2)
VRS-4 pain scale
The pain during the procedure is measured by the four-category verbal rating scale (VRS-4)
Measured: During the whole procedure
State-Trait Anxiety Inventory (STAI)
The anxiety during the procedure is measured by the State - Trait Anxiety Inventory (STAI)
Measured: During the whole procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radial Artery SpasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 424 General Military Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Responsible party
- Principal investigator, Fotios Oikonomou, 424 General Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766151
- Sponsor's protocol ID
- 27
- Acronym
- NURSE-TTS
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36609046
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04766151
- Acronym / sponsor ID
- NURSE-TTS / 27
- Conditions
- Radial Artery Spasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- 424 General Military HospitalUniversity, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdermal glyceryl trinitrate patches | Experimental | Drug: Transdermal glyceryl trinitrate 10mg patches |
| Transdermal placebo patches | Placebo comparator | Drug: Placebo patches |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female 18 -85 years old who has been admitted for scheduled coronary angiography by radial artery
Key exclusion criteria (7 listed)
- Prior same radial artery catheterization
- Positive Allen test
- Severe Hypotension (SBP<100 mmHg)
- Pregnancy
- Ongoing Acute Myocardial Infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal glyceryl trinitrate 10mg patchesAlso: Nitrong tts 10mg- Lavipharm S.A.Transdermal patches applied to skin 30 minutes before cardiac catheterization | Drug | Transdermal glyceryl trinitrate patches |
| Placebo patchesTransdermal placebo patches applied to skin 30 minutes before cardiac catheterization | Drug | Transdermal placebo patches |
Primary outcome
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
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
2 secondary outcomes
VRS-4 pain scale
Time frame: During the whole procedure
State-Trait Anxiety Inventory (STAI)
Time frame: During the whole procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Derived from this study: PubMed 36609046Economou 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.
- Individual participant dataSharing planned: No
Related trials for Radial Artery Spasm
RecruitingObservational study
Radial Access Data in Vascular Interventions Registry
Radial Artery Occlusion, Radial Artery Spasm
Not yet recruiting
Impact of Preprocedural Stress Ball Use on Radial Artery Outcomes in Elective Coronary Angiography
Coronary Arterial Disease (CAD), Radial Artery Spasm
Recruiting
The Effect of Music on Anxiety and Vasospasm in Patients Undergoing Transradial Angiography
Radial Artery Spasm, Anxiety
Not yet recruiting
The Effect of Using Virtual Reality Glasses on Anxiety-related Radial Vasospasm in Patients Undergoing Transradial Coronary Angiography
Radial Artery Spasm, Radial Artery Access
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transdermal glyceryl trinitrate 10mg patches in people with Radial Artery Spasm, run by 424 General Military Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fotios Oikonomou, MD, PhD (00306977618318, economouf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial Spasm occurrence (time frame: Immediately after the end of the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.