Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration. (TRIESTE)

TransRadIal Evaluation STudy of diamEter Increase After Vasodilatory Drugs Administration: The TRIESTE Randomized Study

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Arterial Spasm
• Intervention / Treatment: Other: Intravenous administration of vasodilatory drugs

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 Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vladimir Rubimbura, MD; Phone Number: 0041795565806; Email: vladimir.rubimbura@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Recruiting
      • Rubimbura Vladimir
      • Contact: Vladimir Rubimbura, MD; Email: vladimir.rubimbura@chuv.ch
      • Principal Investigator: Vladimir Rubimbura, MD
      • Sub-Investigator: Stephane Fournier, MD
      • Sub-Investigator: Julien Adjedj, MD, PhD
      • Sub-Investigator: Marion Dupré, MD
      • Sub-Investigator: Mattia Pagnoni, MD
      • Sub-Investigator: David Meier, MD
      • Sub-Investigator: Christan Roguelov, MD
      • Sub-Investigator: Catalina Trana, MD
      • Sub-Investigator: Grégoire Girod, MD
      • Sub-Investigator: Dimitri Arangalage, MD
      • Sub-Investigator: Eric Eeckhout, MD, PhD
      • Sub-Investigator: Olivier Muller, MD, PhD
    • Morges, Vaud, Switzerland, 1110
      • Enrolling by invitation
      • Morges Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Clinical indication for a coronary angiogram by radial route
2. Age ≥18 years old
3. Chronic coronary disease or stable acute coronary syndrome (NSTEMI, Non-ST Elevation Myocardial Infarction)

Exclusion criteria:

1. ST-Elevation Myocardial infarction
2. Severe aortic stenosis (aortic valve area <0.8 cm2 or mean gradient > 40 mmHg)
3. Severe left ventricular dysfunction (left ventricular ejection fraction < 30%).
4. Heart failure, hemodynamic instability or severe hypotension (systolic arterial pressure < 90 mm Hg or heart rate < 45 bpm).
5. Atrioventricular disturbances (atrioventricular block 2° or 3°).
6. Contraindications to the class of drugs used in the trial, e.g. known hypersensitivity or allergy to class of drugs or the investigational
7. Women who are pregnant or breast feeding, Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
8. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
9. Psychological disorders, dementia, etc. of the participant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intra-radial group; intra-radial administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)	Other: Intravenous administration of vasodilatory drugs; Administration of the vasodilatory drugs in a different pattern than intra-arterially
Experimental: Intravenous-post group; intra-venous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)	Other: Intravenous administration of vasodilatory drugs; Administration of the vasodilatory drugs in a different pattern than intra-arterially
Experimental: Intravenous-pre group; intra-venous administration of the vasodilatory drugs 5 minutes before sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)	Other: Intravenous administration of vasodilatory drugs; Administration of the vasodilatory drugs in a different pattern than intra-arterially

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Collaborators: Centre de recherche clinique - FBM-CHUV
• Investigators: Principal Investigator: Vladimir Rubimbura, MD, MD

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; radial spasm; vasodilatory drugs
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Trieste-study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No