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

• Sponsor: Brugmann University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02258620
• Collaborator: (none)
• Enrollment: 442
• Location: 1
• Arms: 3
• Duration (Months): 15
• Patients Per Site Per Month: 29.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronaropathy	Drug: dinitrate isosorbide; Drug: nitroglycerine	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 442 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dinitrate isosorbide (intra venous) dinitrate isosorbide by continuous intra venous injection (1 à 5 mg/h)	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
Experimental: dinitrate isosorbide (intra arterial) dinitrate isosorbide 5 mg by direct administration intra arterial	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
Experimental: nitroglycerine (transdermic) nitroglycerine dermal patch15 mg/24h soit 67,2 mg/21 cm2	Drug: nitroglycerine; nitroglycerine dermal patch 15 mg/24h : 67,2 mg/21 cm2

Outcome Measures

Primary Outcome Measures

1. 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)

2. Probe friction [Day of administration]

   Probe friction, as experienced by the operator (subjective measure)

3. Pain [Day of administration]

   Pain felt by the patient in the forearm (subjective measure)

4. Radial artery occlusion [3 months post procedure]

   Evaluation of the radial artery occlusion 3 months post procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU-Brugmann	Bruxelles		Belgium	1020

Sponsors and Collaborators

• Brugmann University Hospital

Investigators

• Principal Investigator: José Castro, MD, CHU-Brugmann

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: José Castro, Chef de Clinique, Brugmann University Hospital
• ClinicalTrials.gov Identifier: NCT02258620
• Other Study ID Numbers: CHUB-SAR
• First Posted: Oct 7, 2014
• Last Update Posted: Oct 7, 2014
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Nitroglycerin

Study Results

No Results Posted as of Oct 7, 2014