Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.

Coronary Artery Disease Clinical Trial

— TRIESTE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04317846
• Other study ID #: Trieste-study
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: June 26, 2024

Study information

• Verified date: May 2024
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: June 26, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Spasm
• Coronary Artery Disease

Intervention

Other:
• Intravenous administration of vasodilatory drugs
Administration of the vasodilatory drugs in a different pattern than intra-arterially

Locations

Country	Name	City	State
Switzerland	Rubimbura Vladimir	Lausanne	Vaud
Switzerland	Morges Hospital	Morges	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	Centre de recherche clinique - FBM-CHUV

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Hemodynamic changes after vasodilatory drugs administration using the intravenous versus intra-radial route	Measure of arterial pressure	5 minutes after vasodilatory drugs administration
Secondary	Heart rate change after vasodilatory drugs administration using the intravenous versus intra-radial route	Measure of heart rate.	5 minutes after vasodilatory drugs administration