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

NCT02258620 | Completed DMC

• 1 other identifier: CHUB-SAR
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronaropathy

Outcome Measures

Primary Outcomes (4)

• 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

• Probe friction

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

  Day of administration

• Pain

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

  Day of administration

• Radial artery occlusion

  Evaluation of the radial artery occlusion 3 months post procedure

  3 months post procedure

Study Arms (3)

dinitrate isosorbide (intra venous)

EXPERIMENTAL

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

Drug: dinitrate isosorbide

dinitrate isosorbide (intra arterial)

EXPERIMENTAL

dinitrate isosorbide 5 mg by direct administration intra arterial

Drug: dinitrate isosorbide

nitroglycerine (transdermic)

EXPERIMENTAL

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

Drug: nitroglycerine

Interventions

dinitrate isosorbide 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 (intra venous)

nitroglycerine DRUG

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

nitroglycerine (transdermic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 ans.
• Patients with hemodynamic stability.
• Patients informed consent was signed by each individual. The study obtained approval from the local ethics committee.

You may not qualify if:

• 'Test d'Allen' negative
• Pregnancy.
• STEMI
• Hemodynamic Instability : PAS \< 100 mmHg, FC \> 100 bpm, tachycardia uncontrollable.
• Allergy of nitrates.

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU-Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Interventions

Isosorbide; Nitroglycerin

Intervention Hierarchy (Ancestors)

Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Nitro Compounds

Study Officials

• José Castro, MD

  CHU-Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chef de Clinique

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 7, 2014
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

BE (1)