Coronaropathy
Conditions
Brief 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.
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.
Interventions
DRUGdinitrate isosorbide
dinitrate isosorbide (cedocard\*) by continuous intra venous (1 to 5 mg/h) dinitrate isosorbide (cedocard\*) 5 mg by intra arterial direct in the sheat
DRUGnitroglycerine
nitroglycerine dermal patch 15 mg/24h : 67,2 mg/21 cm2
Sponsors
Brugmann University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial artery diameter | Day of administration | With the help of an arterial doppler, measure of the radial artery diameter after injection of dinitrate isosorbide at the beginning and at the end of the procedure (objective measure) |
| Probe friction | Day of administration | Probe friction, as experienced by the operator (subjective measure) |
| Pain | Day of administration | Pain felt by the patient in the forearm (subjective measure) |
| Radial artery occlusion | 3 months post procedure | Evaluation of the radial artery occlusion 3 months post procedure |
Countries
Belgium
Outcome results
None listed