Stroke Clinical Trial
Official title:
Remote Ischemic Preconditioning in High Risk Cardiovascular Surgery Patients: A Randomized Controlled Trial
Remote ischemic preconditioning (RIPC) occurs when a tissue (ex. heart) becomes less
vulnerable to an ischemic insult if a remote tissue (ex. arm) has had previous exposure to a
period of ischemia and reperfusion. A beneficial effect of RIPC has been demonstrated in
several randomized studies in patients undergoing cardiac and vascular surgery, as well as
interventional cardiac procedures such as angioplasty. They have shown improvements in
cardiac, renal, neurologic and respiratory function. Most have focused on surrogate
outcomes, such as biochemical markers of cardiac and renal function in low-risk patients. No
trials have investigated only high-risk patients or been designed to detect clinical
outcomes.
This study is a randomized-controlled trial powered to detect clinical events in a high-risk
cohort undergoing cardiovascular surgery. Patients will be randomized to RIPC (exposed to
cycles of inflation of a blood pressure cuff on the upper arm prior to undergoing surgery)
or control (no ischemic stimulus).
The investigators hypothesize this population will demonstrate lower rates of adverse
ischemic events. The investigators also intend to sample biochemical markers to better
elucidate the mechanism of RIPC and generate hypotheses for future studies and
interventions. Post-operatively the investigators will monitor for adverse clinical outcomes
including cardiac, renal, pulmonary and neurologic injury.
RIPC is simple, inexpensive and easily reproducible and there have been no reports of
adverse consequences. Post-operative ischemic events such as stroke, myocardial infarction,
cardiac, renal and respiratory failure affect patient survival and quality of life, and
represent a sizeable financial burden to health care. If beneficial effects of RIPC are
demonstrated, it will be widely applicable to the entire population of cardiac and vascular
patients resulting in a widely-implemented change in practice.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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