Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.

Coronaropathy Clinical Trial

Official title:

Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258620
• Other study ID #: CHUB-SAR
• Status: Completed
• Phase: N/A
• First received: September 26, 2014
• Last updated: October 3, 2014
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronaropathy

Intervention

Drug:
• dinitrate 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
• nitroglycerine
nitroglycerine dermal patch 15 mg/24h : 67,2 mg/21 cm2

Locations

Country	Name	City	State
Belgium	CHU-Brugmann	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery diameter	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)	Day of administration	Yes
Primary	Probe friction	Probe friction, as experienced by the operator (subjective measure)	Day of administration	Yes
Primary	Pain	Pain felt by the patient in the forearm (subjective measure)	Day of administration	Yes
Primary	Radial artery occlusion	Evaluation of the radial artery occlusion 3 months post procedure	3 months post procedure	Yes