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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04317846
Other study ID # Trieste-study
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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