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

Primary Purpose

Arterial Spasm, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Intravenous administration of vasodilatory drugs
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Spasm focused on measuring radial spasm, percutaneous coronary intervention, vasodilatory drugs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rubimbura VladimirRecruiting
  • Morges Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Intra-radial group

Intravenous-post group

Intravenous-pre group

Arm Description

intra-radial administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)

intra-venous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)

intra-venous administration of the vasodilatory drugs 5 minutes before sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Hemodynamic changes after vasodilatory drugs administration using the intravenous versus intra-radial route
Measure of arterial pressure
Heart rate change after vasodilatory drugs administration using the intravenous versus intra-radial route
Measure of heart rate.

Full Information

First Posted
March 18, 2020
Last Updated
September 25, 2022
Sponsor
University of Lausanne Hospitals
Collaborators
Centre de recherche clinique - FBM-CHUV
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1. Study Identification

Unique Protocol Identification Number
NCT04317846
Brief Title
Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.
Acronym
TRIESTE
Official Title
TransRadIal Evaluation STudy of diamEter Increase After Vasodilatory Drugs Administration: The TRIESTE Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
Collaborators
Centre de recherche clinique - FBM-CHUV

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Spasm, Coronary Artery Disease
Keywords
radial spasm, percutaneous coronary intervention, vasodilatory drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multi-center randomised controlled trial
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-radial group
Arm Type
Active Comparator
Arm Description
intra-radial administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
Arm Title
Intravenous-post group
Arm Type
Experimental
Arm Description
intra-venous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
Arm Title
Intravenous-pre group
Arm Type
Experimental
Arm Description
intra-venous administration of the vasodilatory drugs 5 minutes before sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
Intervention Type
Other
Intervention Name(s)
Intravenous administration of vasodilatory drugs
Intervention Description
Administration of the vasodilatory drugs in a different pattern than intra-arterially
Primary Outcome Measure Information:
Title
Maximal radial artery diameter dilation, measured by echo-doppler, after administration of vasodilatory drugs by intravenous or intra-radial route.
Description
Radial artery diameter
Time Frame
5 minutes after vasodilatory drugs administration
Secondary Outcome Measure Information:
Title
Pain evaluation after vasodilatory drugs administration using the intravenous versus intra-radial route
Description
Scale from 0 to 10, lower values corresponding to lower pain and higher values to intense pain.
Time Frame
Procedure (During vasodilatory drugs administration)
Title
Hemodynamic changes after vasodilatory drugs administration using the intravenous versus intra-radial route
Description
Measure of arterial pressure
Time Frame
5 minutes after vasodilatory drugs administration
Title
Heart rate change after vasodilatory drugs administration using the intravenous versus intra-radial route
Description
Measure of heart rate.
Time Frame
5 minutes after vasodilatory drugs administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Clinical indication for a coronary angiogram by radial route Age ≥18 years old Chronic coronary disease or stable acute coronary syndrome (NSTEMI, Non-ST Elevation Myocardial Infarction) Exclusion criteria: ST-Elevation Myocardial infarction Severe aortic stenosis (aortic valve area <0.8 cm2 or mean gradient > 40 mmHg) Severe left ventricular dysfunction (left ventricular ejection fraction < 30%). Heart failure, hemodynamic instability or severe hypotension (systolic arterial pressure < 90 mm Hg or heart rate < 45 bpm). Atrioventricular disturbances (atrioventricular block 2° or 3°). Contraindications to the class of drugs used in the trial, e.g. known hypersensitivity or allergy to class of drugs or the investigational 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. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.), Psychological disorders, dementia, etc. of the participant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Rubimbura, MD
Phone
0041795565806
Email
vladimir.rubimbura@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Rubimbura, MD
Organizational Affiliation
MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rubimbura Vladimir
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Rubimbura, MD
Email
vladimir.rubimbura@chuv.ch
First Name & Middle Initial & Last Name & Degree
Vladimir Rubimbura, MD
First Name & Middle Initial & Last Name & Degree
Stephane Fournier, MD
First Name & Middle Initial & Last Name & Degree
Julien Adjedj, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marion Dupré, MD
First Name & Middle Initial & Last Name & Degree
Mattia Pagnoni, MD
First Name & Middle Initial & Last Name & Degree
David Meier, MD
First Name & Middle Initial & Last Name & Degree
Christan Roguelov, MD
First Name & Middle Initial & Last Name & Degree
Catalina Trana, MD
First Name & Middle Initial & Last Name & Degree
Grégoire Girod, MD
First Name & Middle Initial & Last Name & Degree
Dimitri Arangalage, MD
First Name & Middle Initial & Last Name & Degree
Eric Eeckhout, MD, PhD
First Name & Middle Initial & Last Name & Degree
Olivier Muller, MD, PhD
Facility Name
Morges Hospital
City
Morges
State/Province
Vaud
ZIP/Postal Code
1110
Country
Switzerland
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

Plan to Share IPD
No

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Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.

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