CompletedNot Applicable

Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.

Switzerland165 participantsStarted 2021-03-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

✕. 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.),

What they're measuring

Maximal radial artery diameter dilation, measured by echo-doppler, after administration of vasodilatory drugs by intravenous or intra-radial route.

Timeframe: 5 minutes after vasodilatory drugs administration

Trial details

NCT IDNCT04317846

SponsorUniversity of Lausanne Hospitals

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-13

View on ClinicalTrials.gov More Arterial Spasm trials