NCT04766151

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

February 15, 2021

Last Update Submit

February 20, 2021

Conditions

Radial Artery Spasm

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • VRS-4 pain scale

    During the whole procedure

  • State-Trait Anxiety Inventory (STAI)

    During the whole procedure

Study Arms (2)

Transdermal glyceryl trinitrate patches

EXPERIMENTAL
Drug: Transdermal glyceryl trinitrate 10mg patches

Transdermal placebo patches

PLACEBO COMPARATOR
Drug: Placebo patches

Interventions

Transdermal glyceryl trinitrate 10mg patchesDRUG

Transdermal patches applied to skin 30 minutes before cardiac catheterization

Also known as: Nitrong tts 10mg- Lavipharm S.A.
Transdermal glyceryl trinitrate patches
Placebo patchesDRUG

Transdermal placebo patches applied to skin 30 minutes before cardiac catheterization

Transdermal placebo patches

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 18 -85 years old who has been admitted for scheduled coronary angiography by radial artery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

424 GeneralMH

Thessaloniki, 56429, Greece

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36609046DERIVED

MeSH Terms

Interventions

Transdermal Patch

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Fotios Oikonomou, MD, PhD

CONTACT

00306977618318economouf@gmail.com

Ioannis Doundoulakis, MD

CONTACT

00306946002830doudougiannis@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Interventional Cardiologist - Head of Cath Lab

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 23, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)