Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.

NCT ID: NCT04317846

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2024-06-30

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)

Conditions

Arterial Spasm; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intra-radial group

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

Group Type: ACTIVE_COMPARATOR

Intravenous administration of vasodilatory drugs

Intervention Type: OTHER

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

Intravenous-post group

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

Group Type: EXPERIMENTAL

Intravenous administration of vasodilatory drugs

Intervention Type: OTHER

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

Intravenous-pre group

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

Group Type: EXPERIMENTAL

Intravenous administration of vasodilatory drugs

Intervention Type: OTHER

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

Interventions

Intravenous administration of vasodilatory drugs

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de recherche clinique - FBM-CHUV

UNKNOWN

Sponsor Role: collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Vladimir Rubimbura

Principal Investigator, Dr Vladimir Rubimbura

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vladimir Rubimbura, MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

Rubimbura Vladimir

Lausanne, Canton of Vaud, Switzerland

Morges Hospital

Morges, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

Trieste-study

Identifier Type: -

Identifier Source: org_study_id