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| Name | Class |
|---|---|
| Centre de recherche clinique - FBM-CHUV | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-radial group | Active Comparator | intra-radial administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg) |
|
| Intravenous-post group | Experimental | intra-venous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous administration of vasodilatory drugs | Other | Administration of the vasodilatory drugs in a different pattern than intra-arterially |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Hemodynamic changes after vasodilatory drugs administration using the intravenous versus intra-radial route |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Rubimbura, MD | MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rubimbura Vladimir | Lausanne | Canton of Vaud | 1011 | Switzerland | ||
| Morges Hospital |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D013035 | Spasm |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Multi-center randomised controlled trial
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Measure of arterial pressure |
| 5 minutes after vasodilatory drugs administration |
| Heart rate change after vasodilatory drugs administration using the intravenous versus intra-radial route | Measure of heart rate. | 5 minutes after vasodilatory drugs administration |
| Morges |
| Canton of Vaud |
| 1110 |
| Switzerland |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |