Back to resultsNitroglycerin Prevents Radial Artery Occlusion (NORAO)
Primary Purpose
Injury of Radial Artery
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
500 microgram of Nitroglycerin
Saline 5 mL
Sponsored by
About this trial
This is an interventional prevention trial for Injury of Radial Artery focused on measuring Nitroglycerin, Radial Artery Occlusion, Transradial Catheterization
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with cardiogenic shock or hemodynamically unstable
- Unable to tolerate nitrates
Sites / Locations
- National Cardiovascular Center Harapan Kita
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
500 microgram of Nitroglycerin
Saline 5 mL
Arm Description
500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure
0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure
Outcomes
Primary Outcome Measures
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT02105493
First Posted
February 19, 2014
Last Updated
April 2, 2014
Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
1. Study Identification
Unique Protocol Identification Number
NCT02105493
Brief Title
Nitroglycerin Prevents Radial Artery Occlusion
Acronym
NORAO
Official Title
A Novel Approach to Reduce Radial Artery Occlusion After Trans-Radial Catheterization: Post-Procedural/Pre-Hemostasis Intra-Arterial Nitroglycerin
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Radial Artery
Keywords
Nitroglycerin, Radial Artery Occlusion, Transradial Catheterization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1706 (Actual)
8. Arms, Groups, and Interventions
Arm Title
500 microgram of Nitroglycerin
Arm Type
Active Comparator
Arm Description
500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure
Arm Title
Saline 5 mL
Arm Type
Placebo Comparator
Arm Description
0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure
Intervention Type
Drug
Intervention Name(s)
500 microgram of Nitroglycerin
Other Intervention Name(s)
NTG
Intervention Description
500 microgram of Nitroglycerin (in 5 mL saline) given intra-arterially through the sheath at the end of transradial procedure
Intervention Type
Drug
Intervention Name(s)
Saline 5 mL
Other Intervention Name(s)
NaCl 0,9% 5mL
Intervention Description
Saline 5 mL given intra-arterially through the sheath at the end of transradial procedure
Primary Outcome Measure Information:
Title
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound
Time Frame
One Day After the Index Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients with cardiogenic shock or hemodynamically unstable
Unable to tolerate nitrates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surya Dharma, MD, PhD
Organizational Affiliation
National Cardiovascular Center Harapan Kita
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cardiovascular Center Harapan Kita
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
12. IPD Sharing Statement
Citations:
PubMed Identifier
26797427
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.
Results Reference
derived
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Nitroglycerin Prevents Radial Artery Occlusion
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