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Nitroglycerin Prevents Radial Artery Occlusion (NORAO)

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ClinicalTrials.gov Identifier: NCT02105493
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Surya Dharma, MD, PhD, National Cardiovascular Center Harapan Kita Hospital Indonesia

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.

Condition or disease Intervention/treatment Phase
Injury of Radial Artery Drug: 500 microgram of Nitroglycerin Drug: Saline 5 mL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A Novel Approach to Reduce Radial Artery Occlusion After Trans-Radial Catheterization: Post-Procedural/Pre-Hemostasis Intra-Arterial Nitroglycerin
Study Start Date : October 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 500 microgram of Nitroglycerin
500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure
Drug: 500 microgram of Nitroglycerin
500 microgram of Nitroglycerin (in 5 mL saline) given intra-arterially through the sheath at the end of transradial procedure
Other Name: NTG

Placebo Comparator: Saline 5 mL
0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure
Drug: Saline 5 mL
Saline 5 mL given intra-arterially through the sheath at the end of transradial procedure
Other Name: NaCl 0,9% 5mL




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105493


Locations
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Indonesia
National Cardiovascular Center Harapan Kita
Jakarta, Indonesia, 11420
Sponsors and Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia
Investigators
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Principal Investigator: Surya Dharma, MD, PhD National Cardiovascular Center Harapan Kita

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Surya Dharma, MD, PhD, MD, PhD, National Cardiovascular Center Harapan Kita Hospital Indonesia
ClinicalTrials.gov Identifier: NCT02105493     History of Changes
Other Study ID Numbers: NORAO2014
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: March 2014
Keywords provided by Surya Dharma, MD, PhD, National Cardiovascular Center Harapan Kita Hospital Indonesia:
Nitroglycerin
Radial Artery Occlusion
Transradial Catheterization
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Nitroglycerin
Vasodilator Agents