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

Sponsor

University of Lausanne Hospitals (Other)

Overall Status

Unknown status

CT.gov ID

NCT04317846

Collaborator

Centre de recherche clinique - FBM-CHUV (Other)

384

Enrollment

Location

Arms

Anticipated Duration (Months)

32.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Spasm Coronary Artery Disease	Other: Intravenous administration of vasodilatory drugs	N/A

Detailed Description

Single center, 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. 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): intravenous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
Group 3 (intravenous-pre): intravenous administration of the vasodilatory drugs 5 minutes before sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

384 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single-center randomised controlled trialSingle-center randomised controlled trial

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Mar 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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
Hemodynamic changes after vasodilatory drugs administration using the intravenous versus intra-radial route [5 minutes after vasodilatory drugs administration]
Measure of heart rate.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Refusal of participation in the study
Previous coronary angiography performed by radial route
Presence of verapamil or nitrates in the current pharmacological treatment of the patient
STEMI, ST Elevation Myocardial Infarction
Allergy/intolerance to verapamil or nitrates
Severe aortic valvular stenosis
Left ventricular ejection fraction <30%
Heart failure signs or hemodynamic instability

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rubimbura Vladimir	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

University of Lausanne Hospitals
Centre de recherche clinique - FBM-CHUV

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vladimir Rubimbura, Principal Investigator, Dr Vladimir Rubimbura, University of Lausanne Hospitals

ClinicalTrials.gov Identifier:

NCT04317846

Other Study ID Numbers:

Trieste-study

First Posted:

Mar 23, 2020

Last Update Posted:

Mar 23, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Vladimir Rubimbura, Principal Investigator, Dr Vladimir Rubimbura, University of Lausanne Hospitals

radial spasm

percutaneous coronary intervention

vasodilatory drugs

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Mar 23, 2020