Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Arterial Spasm
• Interventions: Other: Intravenous administration of vasodilatory drugs

• Registration Number: NCT04317846
• Lead Sponsor: University of Lausanne Hospitals

Brief Summary

Radial artery access use in percutaneous cardiac interventions (PCI) is associated with a lower risk of vascular complications, bleeding and major adverse cardiac events including cardiac death in the long-term follow-up. Intra-radial administration of vasodilatory drugs, transiently painful for the patient, reduces the risk of spasm and is currently the standard technique performed worldwide. However, the efficacy of intravenous administration of vasodilatory drugs has never been evaluated.

Detailed Description

Multicenter, randomised controlled trial, designed to evaluate the noninferiority of the intravenous administration of vasodilatory drugs in comparison with the actual gold standard intra-arterial radial route, in terms of radial artery diameter increase.

All consecutive patients with stable ischemic disease or stable acute coronary syndrome (NSTEMI - Non-ST elevation myocardial infarction) for whom a coronary procedure is planned will be included in the study. Three groups will be constituted. For all groups, the diameters of both radial arteries will be measured thrice by echo-Doppler: 5 minutes before sheath insertion, immediately before sheath insertion and 5 minutes after sheath insertion. Pain evaluation will be performed after injection of the vasodilatory drugs/placebo in the radial artery:

* Group 1 (control group): intra-radial administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)

* Group 2 (intravenous-post): intra-venous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)

* Group 3 (intravenous-pre): intra-venous administration of the vasodilatory drugs 5 minutes before sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)

Study Timeline

• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Study Start: 2021-03-22
• Primary Completion: 2024-02-13
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-radial group	Intravenous administration of vasodilatory drugs	intra-radial administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
Intravenous-pre group	Intravenous administration of vasodilatory drugs	intra-venous administration of the vasodilatory drugs 5 minutes before sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
Intravenous-post group	Intravenous administration of vasodilatory drugs	intra-venous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)

Primary Outcome Measures

Name	Time	Method
Maximal radial artery diameter dilation, measured by echo-doppler, after administration of vasodilatory drugs by intravenous or intra-radial route.	5 minutes after vasodilatory drugs administration	Radial artery diameter

Secondary Outcome Measures

Name	Time	Method
Pain evaluation after vasodilatory drugs administration using the intravenous versus intra-radial route	Procedure (During vasodilatory drugs administration)	Scale from 0 to 10, lower values corresponding to lower pain and higher values to intense pain.
Hemodynamic changes after vasodilatory drugs administration using the intravenous versus intra-radial route	5 minutes after vasodilatory drugs administration	Measure of arterial pressure
Heart rate change after vasodilatory drugs administration using the intravenous versus intra-radial route	5 minutes after vasodilatory drugs administration	Measure of heart rate.

Trial Locations

Locations (2)

Rubimbura Vladimir; 🇨🇭 Lausanne, Vaud, Switzerland

Morges Hospital; 🇨🇭 Morges, Vaud, Switzerland