Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT04766151
Status:
UNKNOWN
Last Update Posted:
2021-02-23
First Post:
2021-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nitrate Use to Obtain Radial Spasm Embarrassment (NURSE - TTS Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057968', 'term': 'Transdermal Patch'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-20', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-20', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radial Spasm occurrence', 'timeFrame': 'Immediately after the end of the procedure', 'description': 'Radial spasm is measured by the exerting force (in Newton) removing the sheath from the patient'}, {'measure': 'Successful radial puncture', 'timeFrame': 'During radial puncture and catheterization', 'description': 'The success is defined by the fast radial puncture and catheterization and is measured by the time of radial catheterization'}], 'secondaryOutcomes': [{'measure': 'VRS-4 pain scale', 'timeFrame': 'During the whole procedure', 'description': 'The pain during the procedure is measured by the four-category verbal rating scale (VRS-4)'}, {'measure': 'State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'During the whole procedure', 'description': 'The anxiety during the procedure is measured by the State - Trait Anxiety Inventory (STAI)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radial Artery Spasm']}, 'referencesModule': {'references': [{'pmid': '36609046', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18 -85 years old who has been admitted for scheduled coronary angiography by radial artery\n\nExclusion Criteria:\n\n* Prior same radial artery catheterization\n* Positive Allen test\n* Severe Hypotension (SBP\\<100 mmHg)\n* Pregnancy\n* Ongoing Acute Myocardial Infarction\n* Ongoing cardiogenic shock\n* Known History of Nitrates intolerance/allergy'}, 'identificationModule': {'nctId': 'NCT04766151', 'acronym': 'NURSE-TTS', 'briefTitle': 'Nitrate Use to Obtain Radial Spasm Embarrassment (NURSE - TTS Trial)', 'organization': {'class': 'OTHER', 'fullName': '424 General Military Hospital'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transdermal glyceryl trinitrate patches', 'interventionNames': ['Drug: Transdermal glyceryl trinitrate 10mg patches']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Transdermal placebo patches', 'interventionNames': ['Drug: Placebo patches']}], 'interventions': [{'name': 'Transdermal glyceryl trinitrate 10mg patches', 'type': 'DRUG', 'otherNames': ['Nitrong tts 10mg- Lavipharm S.A.'], 'description': 'Transdermal patches applied to skin 30 minutes before cardiac catheterization', 'armGroupLabels': ['Transdermal glyceryl trinitrate patches']}, {'name': 'Placebo patches', 'type': 'DRUG', 'description': 'Transdermal placebo patches applied to skin 30 minutes before cardiac catheterization', 'armGroupLabels': ['Transdermal placebo patches']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56429', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Fotios Oikonomou, MD, PhD', 'role': 'CONTACT', 'email': 'economouf@gmail.com', 'phone': '+306977618318'}, {'name': 'Fotios Oikonomou, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ioannis Doundoulakis, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Myrto Samara, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Iliada Kalamakidou, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Georgios Papazisis, MD, Phd', 'role': 'SUB_INVESTIGATOR'}], 'facility': '424 GeneralMH', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Fotios Oikonomou, MD, PhD', 'role': 'CONTACT', 'email': 'economouf@gmail.com', 'phone': '00306977618318'}, {'name': 'Ioannis Doundoulakis, MD', 'role': 'CONTACT', 'email': 'doudougiannis@gmail.com', 'phone': '00306946002830'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '424 General Military Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Interventional Cardiologist - Head of Cath Lab', 'investigatorFullName': 'Fotios Oikonomou', 'investigatorAffiliation': '424 General Military Hospital'}}}}