Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-13 @ 12:53 PM
Study NCT ID:
NCT02105493
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2014-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitroglycerin Prevents Radial Artery Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1706}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound', 'timeFrame': 'One Day After the Index Procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nitroglycerin', 'Radial Artery Occlusion', 'Transradial Catheterization'], 'conditions': ['Injury of Radial Artery']}, 'referencesModule': {'references': [{'pmid': '26797427', 'type': 'DERIVED', 'citation': 'Dharma S, Kedev S, Patel T, Sukmawan R, Gilchrist IC, Rao SV. Post-procedural/pre-hemostasis intra-arterial nitroglycerin after transradial catheterization: A gender based analysis. Cardiovasc Revasc Med. 2016 Jan-Feb;17(1):10-4. doi: 10.1016/j.carrev.2015.12.002. Epub 2015 Dec 22.'}]}, 'descriptionModule': {'briefSummary': 'Trans-radial approach (TRA) has becoming popular and widely adopted over the last decade. However, radial artery occlusion (RAO) continues to be one of the limitation of trans-radial access and potentially limits the radial artery as an access site in the future. Several strategies have been used to decrease the incidence of RAO including the use of anticoagulation, maintenance of patency during hemostasis, or shortening the duration of compression. Currently, there is no data whether vasoactive pharmacological therapy such as nitroglycerin administered intra-arterially at the end of the procedure may reduce the incidence of RAO. It is hypothesized that the addition of nitroglycerin (nitric oxide donor) at the end of a TRA procedure may reduce the incidence of RAO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sequential patients undergoing trans-radial catheterization in the institution will be consented to be randomized to receive either 500 microgram nitroglycerin (Group A) or a placebo (Group B) administered intra-arterially through the sheath at the end of the procedure.\n\nExclusion Criteria:\n\n* Patients with cardiogenic shock or hemodynamically unstable\n* Unable to tolerate nitrates'}, 'identificationModule': {'nctId': 'NCT02105493', 'acronym': 'NORAO', 'briefTitle': 'Nitroglycerin Prevents Radial Artery Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'National Cardiovascular Center Harapan Kita Hospital Indonesia'}, 'officialTitle': 'A Novel Approach to Reduce Radial Artery Occlusion After Trans-Radial Catheterization: Post-Procedural/Pre-Hemostasis Intra-Arterial Nitroglycerin', 'orgStudyIdInfo': {'id': 'NORAO2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '500 microgram of Nitroglycerin', 'description': '500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure', 'interventionNames': ['Drug: 500 microgram of Nitroglycerin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline 5 mL', 'description': '0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure', 'interventionNames': ['Drug: Saline 5 mL']}], 'interventions': [{'name': '500 microgram of Nitroglycerin', 'type': 'DRUG', 'otherNames': ['NTG'], 'description': '500 microgram of Nitroglycerin (in 5 mL saline) given intra-arterially through the sheath at the end of transradial procedure', 'armGroupLabels': ['500 microgram of Nitroglycerin']}, {'name': 'Saline 5 mL', 'type': 'DRUG', 'otherNames': ['NaCl 0,9% 5mL'], 'description': 'Saline 5 mL given intra-arterially through the sheath at the end of transradial procedure', 'armGroupLabels': ['Saline 5 mL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11420', 'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'National Cardiovascular Center Harapan Kita', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Surya Dharma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cardiovascular Center Harapan Kita'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cardiovascular Center Harapan Kita Hospital Indonesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Surya Dharma, MD, PhD', 'investigatorAffiliation': 'National Cardiovascular Center Harapan Kita Hospital Indonesia'}}}}