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

NCT ID: NCT02258620

Last Updated: 2014-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-09-30

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.

Conditions

Coronaropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dinitrate isosorbide (intra venous)

dinitrate isosorbide by continuous intra venous injection (1 à 5 mg/h)

Group Type: EXPERIMENTAL

dinitrate isosorbide

Intervention Type: DRUG

dinitrate isosorbide (cedocard\*) by continuous intra venous (1 to 5 mg/h) dinitrate isosorbide (cedocard\*) 5 mg by intra arterial direct in the sheat

dinitrate isosorbide (intra arterial)

dinitrate isosorbide 5 mg by direct administration intra arterial

Group Type: EXPERIMENTAL

dinitrate isosorbide

Intervention Type: DRUG

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 (transdermic)

nitroglycerine dermal patch15 mg/24h soit 67,2 mg/21 cm2

Group Type: EXPERIMENTAL

nitroglycerine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

nitroglycerine

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brugmann University Hospital

OTHER

Sponsor Role: lead

Responsible Party

José Castro

Chef de Clinique

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Castro, MD

Role: PRINCIPAL_INVESTIGATOR

CHU-Brugmann

Locations

CHU-Brugmann

Brussels, , Belgium

Countries

Belgium

Other Identifiers

CHUB-SAR

Identifier Type: -

Identifier Source: org_study_id