Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.
Information source: Brugmann University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronaropathy
Intervention: dinitrate isosorbide (Drug); nitroglycerine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Brugmann University Hospital Official(s) and/or principal investigator(s): José Castro, MD, Principal Investigator, Affiliation: CHU-Brugmann
Summary
The radial approach for a coronary angiography is currently adopted by several centers
because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in
intra-arterial have been widely studied in prevention of this spasm. No studies have
compared the different routes of administration of nitrates as a patch and a continuous
intravenous injection.
Clinical Details
Official title: Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Radial artery diameterProbe friction Pain Radial artery occlusion
Detailed description:
The radial approach is favored for coronary angiography due of several advantages: reduction
of local bleeding risk, even in the most hemorragiparic situations, decreased downtime and
time reduction of hospitalization, improved patient ulterior comfort. However, this approach
is subject to an immediate major complication that is the radial artery spasm (RAS) which,
according to the criteria used, has an average incidence of 30%. The administration of a
vasodilator just before coronary angiography procedure enables an increase of the radial
artery diameter and thus a decrease of friction probes. Theoretically this prevents the
occurrence of the RAS.
The literature re-counts several vasodilator product tests (DN calcic blocker, magnesium
sulfate, alpha-adrenergic antagonist ...) and various routes of administration (direct
intravenous route (IV), subcutaneous injected route, direct intra-arterial route (IA)).
Overall intra-arterial DN appears to be more efficient. The downside is a brief, painful
thermal sensation but intense and notably unpleasant. IV injection is better tolerated but
it was a direct injection and without proof of its superiority over IA. The para-radial
subcutaneous injection has only been studied to facilitate access to the radial artery. The
investigators randomized study compares, for the first time, the effectiveness of the
transdermal administration of trinitrine (D) and continuous intravenous of dinitrate
isosorbide (V) to dinitrate isosorbide intraarterial (A) standard.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients > 18 ans.
- Patients with hemodynamic stability.
- Patients informed consent was signed by each individual. The study obtained approval
from the local ethics committee.
Exclusion Criteria:
- 'Test d'Allen' negative
- Pregnancy.
- STEMI
- Hemodynamic Instability : PAS < 100 mmHg, FC > 100 bpm, tachycardia uncontrollable.
- Allergy of nitrates.
Locations and Contacts
CHU-Brugmann, Bruxelles 1020, Belgium
Additional Information
Starting date: June 2013
Last updated: October 3, 2014
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