Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.

NCT04317846 | Completed DMC

• 1 other identifier: Trieste-study
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

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.

Conditions

Arterial Spasm; Coronary Artery Disease

Keywords

radial spasm; percutaneous coronary intervention; vasodilatory drugs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Intra-radial group

ACTIVE COMPARATOR

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

Intravenous-post group

EXPERIMENTAL

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

Intravenous-pre group

EXPERIMENTAL

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

Interventions

Intravenous administration of vasodilatory drugs OTHER

Administration of the vasodilatory drugs in a different pattern than intra-arterially

Intra-radial group; Intravenous-post group; Intravenous-pre group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lausanne Hospitals: lead
• Centre de recherche clinique - FBM-CHUV: collaborator

Study Sites (2)

Rubimbura Vladimir

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Morges Hospital

Morges, Canton of Vaud, 1110, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Spasm

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vladimir Rubimbura, MD

  MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Dr Vladimir Rubimbura

Model Details: Multi-center randomised controlled trial

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 23, 2020
• Study Start: March 22, 2021
• Primary Completion: February 13, 2024
• Study Completion: June 30, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)