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| Name | Class |
|---|---|
| Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | OTHER |
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The study objective is to verify if a non-invasive remote ischemic preconditioning procedure (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Sham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass. A 20 mm Hg blood pressure cuff on the right arm does not induce ischemia. |
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| Intervention group | Experimental | Remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 200 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood pressure cuff inflation | Procedure | Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in biochemical markers of myocardial ischemia | Troponin T-HS and CK-MB concentration | 6, 12, 24 and 48 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative complications | Monitoring the safety of the strategy by monitoring post-operative complications | post-operatively until 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Voisine, MD | University Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Laval | Québec | Quebec | G1V 4G5 | Canada |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized controlled prospective trial
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Participant is blinded to group assignment
| D014694 |
| Ventricular Outflow Obstruction |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |