Nitroglycerin Prevents Radial Artery Occlusion
Information source: National Cardiovascular Center Harapan Kita Hospital Indonesia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Injury of Radial Artery
Intervention: 500 microgram of Nitroglycerin (Drug); Saline 5 mL (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Cardiovascular Center Harapan Kita Hospital Indonesia Official(s) and/or principal investigator(s):
Surya Dharma, MD, PhD, Principal Investigator, Affiliation: National Cardiovascular Center Harapan Kita
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.
Clinical Details
Official title: A Novel Approach to Reduce Radial Artery Occlusion After Trans-Radial Catheterization: Post-Procedural/Pre-Hemostasis Intra-Arterial Nitroglycerin
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Primary outcome: Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
National Cardiovascular Center Harapan Kita, Jakarta 11420, Indonesia
Additional Information
Starting date: October 2013
Last updated: April 2, 2014
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