TransRadIal Evaluation STudy of diamEter Increase After Vasodilatory Drugs Administration: The TRIESTE Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arterial Spasm
- Sponsor
- University of Lausanne Hospitals
- Enrollment
- 165
- Locations
- 2
- Primary Endpoint
- Maximal radial artery diameter dilation, measured by echo-doppler, after administration of vasodilatory drugs by intravenous or intra-radial route.
- Status
- Completed
- Last Updated
- last year
Overview
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)
Investigators
Vladimir Rubimbura
Principal Investigator, Dr Vladimir Rubimbura
University of Lausanne Hospitals
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximal radial artery diameter dilation, measured by echo-doppler, after administration of vasodilatory drugs by intravenous or intra-radial route.
Time Frame: 5 minutes after vasodilatory drugs administration
Radial artery diameter
Secondary Outcomes
- Pain evaluation after vasodilatory drugs administration using the intravenous versus intra-radial route(Procedure (During vasodilatory drugs administration))
- Hemodynamic changes after vasodilatory drugs administration using the intravenous versus intra-radial route(5 minutes after vasodilatory drugs administration)
- Heart rate change after vasodilatory drugs administration using the intravenous versus intra-radial route(5 minutes after vasodilatory drugs administration)